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Background India currently has more than 60 million people with Type 2 Diabetes Mellitus ( T2DM ) and this is predicted to increase by nearly two-thirds by 2030 . While management of those with T2DM is important , preventing or delaying the onset of the disease , especially in those individuals at ‘ high risk ’ of developing T2DM , is urgently needed , particularly in re source -constrained setting s. This paper describes the protocol for a cluster r and omised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala , India . Methods / design A total of 60 polling booths are r and omised to the intervention arm or control arm in rural Kerala , India . Data collection is conducted in two steps . Step 1 ( Home screening ) : Participants aged 30–60 years are administered a screening question naire . Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic ( Step 2 ) . At the mobile clinic , participants complete question naires , undergo physical measurements , and provide blood sample s for biochemical analysis . Participants identified with T2DM at Step 2 are excluded from further study participation . Participants in the control arm are provided with a health education booklet containing information on symptoms , complications , and risk factors of T2DM with the recommended levels for primary prevention . Participants in the intervention arm receive : ( 1 ) eleven peer-led small group sessions to motivate , guide and support in planning , initiation and maintenance of lifestyle changes ; ( 2 ) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors , prevention and management ; ( 3 ) a participant h and book containing information primarily on peer support and its role in assisting with lifestyle modification ; ( 4 ) a participant workbook to guide self-monitoring of lifestyle behaviours , goal setting and goal review ; ( 5 ) the health education booklet that is given to the control arm . Follow-up assessment s are conducted at 12 and 24 months . The primary outcome is incidence of T2DM . Secondary outcomes include behavioural , psychosocial , clinical , and biochemical measures . An economic evaluation is planned . Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other re source -constrained setting s . Trial registration Australia and New Zeal and Clinical Trials Registry : ACTRN12611000262909 RATIONALE , AIMS AND OBJECTIVES Peer review groups are considered helpful for quality improvement in primary care . An interactive educational programme for small peer groups was developed , focusing on the implementation of newly developed treatment guidelines . The aim is to evaluate the effect of the programme on adherence to treatment guidelines in general practice . METHODS A cluster r and omized trial using a balanced incomplete block design was used ; one arm received a programme on treatment of chronic heart failure ( CHF ) , the other on hypertension treatment in diabetes mellitus type 2 ( T2DM ) . A r and om sample of 10 CHF and 10 T2DM patients per GP was drawn , for whom data were extracted from electronic patient records 1 years before and 6 months after the intervention . The outcomes were prescribing of ACE inhibitors , and antihypertensive treatment in T2DM . The effect was analysed separately for both programmes using multilevel regression models . RESULTS All 27 peer review groups in one region in the Netherl and s were r and omized , of which 16 participated . No significant effects were observed in the CHF group or in the T2DM group . The opportunity for change was limited , as only 53 % of the CHF patients and 60 % of the T2DM patients had a contact with their GP between the intervention and follow-up measurement . CONCLUSION The peer review programme was not successful for changing the treatment of chronic patients , although the programme focused on dealing with barriers perceived by the participants . Not all problems perceived can be solved in a peer group discussion Introduction : Type 2 diabetes mellitus ( T2DM ) is a major health issue in New Zeal and Māori . Clinical trials have demonstrated potential for the prevention of T2DM , but whether community public health programmes aim ing to prevent diabetes are effective is untested . Objective : To describe the planning and design of an intervention aim ing to translate T2DM prevention clinical trial evidence into a community-wide population health intervention in a high risk predominantly Māori community . Approach : Community concerns about the diabetes burden were heard by the local diabetes nurse , herself a tribal member , and discussed with a locally raised academic . Project planning ensued . The intervention and its evaluation were design ed using a participatory community development model . The planned intervention had three components : community-wide health promotion initiatives conveying healthy lifestyle messages , community education and monitoring for identified high-risk individuals and their extended families , and a structural strategy aim ed at adapting local environments to support lifestyle changes . The evaluation plan involved interrupted time series surveys coupled with formative and process evaluations rather than a r and omised control trial design . Discussion : Consulting communities , validating community concerns and prioritising cultural and ethical issues were key steps . Time spent developing good relationships amongst the health provider and academic research team members at the outset proved invaluable , as the team were united in addressing the project planning and implementation challenges , such as funding obstacles that arose because of our ethically and culturally appropriate non-r and omised control trial evaluation design . The pre-intervention survey demonstrated high rates of diabetes ( 13 % ) , insulin resistance ( 33 % ) and risk factors , and provided evidence for positive , as opposed to negative , lifestyle intervention messages . Conclusion : Community-wide lifestyle interventions have the potential to reduce rates of type 2 diabetes and other chronic diseases in high-risk communities , but require a high level of commitment from the health sector and buy-in from the community . Adequate commitment , leadership , planning and re sources are essential Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus ( T2DM ) . Latent phase identification through screening requires structured , appropriately targeted population -based approaches . Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from r and omised intervention trials in screen-detected T2DM cases . UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM . To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care . Here we describe the rationale and methods of a systematic community screening programme and r and omised controlled trial of cardiovascular risk management within a UK multiethnic setting ( ADDITION-Leicester ) . Design A single-blind cluster r and omised , parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care . Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practice s coordinated from a single academic research centre . Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40 - 75 years ( 25 - 75 years South Asian ) . Volunteers also provide detailed medical and family histories ; complete health question naires , undergo anthropometric measures , lipid profiling and a proteinuria assessment . Primary outcome is reduction in modelled Coronary Heart Disease ( UKPDS CHD ) risk at five years .  Seven thous and ( 30 % of South Asian ethnic origin ) volunteers over three years will be recruited to identify a screen-detected T2DM cohort ( n = 285 ) powered to detected a 6 % relative difference ( 80 % power , alpha 0.05 ) between treatment groups at one year . R and omisation will occur at practice -level with newly diagnosed T2DM cases receiving either conventional ( according to current national guidelines ) or intensive ( algorithmic target-driven multi-factorial cardiovascular risk intervention ) treatments . Discussion ADDITION-Leicester is the largest multiethnic ( targeting > 30 % South Asian recruitment ) community T2DM and vascular risk screening programme in the UK . By assessing feasibility and efficacy of T2DM screening , it will inform national disease prevention policy and contribute significantly to our underst and ing of the health care needs of UK South Asians . Trial registration Clinical trial.gov ( NCT00318032 ) Technology and improved care coordination models can help diabetes educators and providers meet national care st and ards and provide culturally sensitive diabetes education that may improve diabetes outcomes . The purpose of the study was to evaluate the clinical usefulness of a nurse-led diabetes care program ( Comprehensive Diabetes Management Program , CDMP ) for poorly controlled Hispanic type 2 diabetes ( T2DM ) patients in an urban community health center setting . Patients were r and omized to the intervention condition ( IC ; n = 21 ) or an attention control condition ( AC ; n = 18 ) . IC and AC conditions were compared on rates of adherence to national clinical practice guidelines ( blood glucose , blood pressure , foot exam , eye exam ) , and levels of diabetes distress , depression , and treatment satisfaction . IC patients had a significant improvement in A1C from baseline to 12-month follow-up compared with AC ( −1.6 % ± 1.4 % versus −0.6 % ± 1.1 % ; P = .01 ) . The proportion of IC patients meeting clinical goals at follow-up tended to be higher than AC for A1c ( IC = 45 % ; AC = 28 % ) , systolic blood pressure ( IC = 55 % ; AC = 28 % ) , eye screening ( IC = 91 % ; AC = 78 % ) , and foot screening , ( IC = 86 % ; AC = 72 % ) . Diabetes distress and treatment satisfaction also showed greater improvement for IC than AC ( P = .05 and P = .06 , respectively ) , with no differences for depression . The CDMP intervention was more effective than an attention control condition in helping patients meet evidence -based guidelines for diabetes care This article reports on the development and pilot feasibility testing of a culturally competent intervention of education and care for black women with type 2 diabetes mellitus ( T2DM ) . Using a one group , pretest posttest quasi-experimental design , the intervention was tested with a convenience sample of 25 community black women with T2DM . The conceptual basis , process , and content of the intervention as well as the feasibility and acceptability of study material s and methods are described . Significant improvements from baseline to 3 months were observed in measures of glycemic control , weight , body mass index , and diabetes-related emotional distress . The findings suggest that a culturally sensitive intervention of nurse practitioner diabetes care and education is beneficial for black women with T2DM , result ing in program attendance , kept appointments , improved glycemic control and weight , and decreased diabetes-related emotional distress Aims Type 2 diabetes mellitus ( T2DM ) , a serious and prevalent chronic disease , is traditionally associated with older age . However , due to the rising rates of obesity and sedentary lifestyles , it is increasingly being diagnosed in the younger population . Sedentary ( sitting ) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes , including T2DM . Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM . We aim ed to investigate , through a r and omised controlled trial ( RCT ) design , whether a group-based structured education workshop focused on sitting reduction , with self-monitoring , reduced sitting time . Methods Adults aged 18–40 years who were either overweight ( with an additional risk factor for T2DM ) or obese were recruited for the Sedentary Time ANd Diabetes ( ST AND ) RCT . The intervention programme comprised of a 3-hour group-based structured education workshop , use of a self-monitoring tool , and follow-up motivational phone call . Data were collected at three time points : baseline , 3 and 12 months after baseline . The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months . Secondary outcomes included other objective ( activPAL ) and self-reported measures of sedentary behaviour and physical activity , and biochemical , anthropometric , and psycho-social variables . Results 187 individuals ( 69 % female ; mean age 33 years ; mean BMI 35 kg/m2 ) were r and omised to intervention and control groups . 12 month data , when analysed using intention-to-treat analysis ( ITT ) and per- protocol analyses , showed no significant difference in the primary outcome variable , nor in the majority of the secondary outcome measures . Conclusions A structured education intervention design ed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months . Lack of change may be due to the brief nature of such an intervention and lack of focus on environmental change . Moreover , some participants reported a focus on physical activity rather than reductions in sitting per se . The habitual nature of sedentary behaviour means that behaviour change is challenging . Trial Registration Controlled-Trials.com IS RCT OBJECTIVE To evaluate the impact of a multifaceted , school-based intervention on inner city youth at high risk for type 2 diabetes mellitus ( T2DM ) and to determine whether the addition of coping skills training ( CST ) and health coaching improves outcomes . METHOD 198 students in New Haven , CT at risk for T2DM ( BMI > 85th percentile and family history of diabetes ) were r and omized by school to an educational intervention with or without the addition of CST and health coaching .  Students were enrolled from 2004 to 2007 and followed for 12 months . RESULTS Students in both groups showed some improvement in anthropometric measures , lipids , and depressive symptoms over 12 months . BMI was not improved by the intervention . Students who received CST showed greater improvement on some indicators of metabolic risk than students who received education only . CONCLUSION A multifaceted , school-based intervention may hold promise for reducing metabolic risk in urban , minority youth This systematic overview summarizes the relevant evidence from multiple systematic review s of the benefits of nonpharmacological interventions for preventing  type 2 diabetes mellitus ( T2MD ) in women diagnosed with gestational diabetes mellitus ( GDM ) . A comprehensive search using the Cochrane Library , CINAHL , EMBASE and MEDLINE via Ovid SP , and PubMed data bases was completed on 18 November 2015 . Any systematic review s that evaluated r and omized controlled trials ( RCTs ) with defined nonpharmacological interventions for preventing T2DM in women diagnosed with GDM were eligible for inclusion . The authors independently performed critical appraisal s and quality assessment s of the included review s using the AMSTAR tool , and extracted data were converted to coherent values for tabular summarization . Six eligible review s of diet and /or exercise , breastfeeding , and reminder interventions were identified ; however , the method ologies of the review s varied greatly , and the majority of the evidence suggested unclear bias . We found inconsistent reporting on the rates at which diet and exercise interventions reduced the risk of T2DM progression , but these interventions were found to be effective at reducing glycemic load . Combined diet , exercise , and breastfeeding interventions proved to be effective at returning women to their postpartum weight . Neither diet alone nor exercise alone proved to be effective at lowering the risk of T2DM . Overall , there was no robust evidence to support the hypothesis that nonpharmacological interventions are effective at lowering the risk of T2DM in women diagnosed with GDM , and there was no consistent evidence showing that these interventions improved the predictor outcomes of T2DM , such as glycemic load or anthropometric changes Introduction This study investigated the outcomes and identified influencing factors of intensive integrated intervention over 2 years in Chinese patients with impaired glucose regulation ( IGR ) . Methods Adults in Beijing , China , were screened for IGR using the 75 g oral glucose tolerance test . Participants with IGR received lifestyle and health education ; those who still had IGR after 1 year were r and omly assigned to either a routine care group or to an intensive integrated intervention group . Results Of 2344 adults screened , 463 had IGR . Of these , 210 adults had IGR after 1 year and were therefore recruited and r and omized to an intensive integrated intervention group ( n=106 ) or a control group ( n=104 ) . The percentage of patients who reached the set targets of plasma glucose , blood pressure , body mass index , or triglycerides was significantly higher in the intensive integrated intervention group . None of the patients within the intensive integrated intervention group progressed to diabetes , whereas eight ( 9.3 % ) cases of the control group developed type 2 diabetes mellitus ( T2DM ) . Logistic regression analysis showed that both an increase in waist circumference and systolic blood pressure ( SBP ) were positively correlated with the development of T2DM , whereas improvement in islet beta cell function was negatively correlated with the development of T2DM . Conclusions Intensive integrated intervention may significantly decrease the conversion rate of IGR to T2DM , and increase the conversion ratio to normal glucose tolerance . The increase of waist circumference or SBP and the deterioration of islet beta cell function may be important risk factors for progression from prediabetes to diabetes Among the more than 20 million Americans who have diabetes , approximately 30 % of the cases are undiagnosed ( 1 ) . An additional 42 million people in the United States have pre-diabetes ( impaired glucose tolerance [ IGT ] , impaired fasting glucose , or both ) , a condition that often leads to diabetes if it is not treated ( 1 ) . The dramatic 41 % increase in prevalence of diabetes during the 1990s was characterized by a shift to a younger age at onset . The prevalence of diabetes increased more than 70 % in the age-group 30 to 39 years ( 1 ) . The longer the duration of poorly controlled diabetes , the greater the risk for development of vascular complications , including retinopathy , end-stage kidney disease , neuropathy , and coronary artery disease . These complications are not only debilitating but also expensive . In 2002 , health-care costs for diabetes in the United States surpassed $ 132 billion ( 1 ) . These costs were primarily related to the treatment and consequences of complications of diabetes ( 2 ) . Several large prospect i ve studies have shown that intensive treatment of diabetes can decrease the chronic complications associated with this disease ( 3 - 6 ) . There seems to be no glycemic threshold for reduction of complications ; the lower the hemoglobin A1c ( A1C ) level , the lower the rate of occurrence of diabetes-related complications ( 7 ) . Advances in pharmacologic therapies and new treatment technologies can facilitate reduction of blood glucose values in patients with diabetes to near-normal and achieve glycemic goal levels recommended in current practice guidelines . Nevertheless , the management of patients with diabetes in the United States has actually worsened during the past decade ( 8) . Data from the National Health and Nutrition Examination Survey III in 1994 showed that only 44 % of patients with type 2 diabetes achieved an A1C level of less than 7 % ( 9 ) . By the year 2000 , this proportion actually decreased to 37 % ( 10 ) . Recently , at an American Association of Clinical Endocrinologists ( AACE ) meeting , a report on the state of diabetes health showed that , in a study of 157,000 Americans in 39 states , two-thirds of the subjects with type 2 diabetes had A1C values above the American College of Endocrinology ( ACE ) goal for glycemic control of 6.5 % or less ( American College of Endocrinology/ American Association of Clinical Endocrinologists . State of Diabetes in America : Striving for Better Control . Available at : http://www.aace.com/pub/StateofDiabetes/ stateofdiabetes.php ) . Clearly , more aggressive and comprehensive application of these available treatment options , supported by diabetes education , is needed . On January 31 , 2005 , ACE and AACE convened a 2day consensus conference to review current research and address questions relevant to the treatment of diabetes . The conference brought together US and international diabetes research ers , clinical and educational experts , and ACE/AACE CONSENSUS CONFERENCE ON THE IMPLEMENTATION OF OUTPATIENT MANAGEMENT OF DIABETES MELLITUS : CONSENSUS CONFERENCE Purpose The purpose of this study was to test the impact of distributing coupons redeemable at farmers markets plus an educational intervention on fruit and vegetable ( F&V ) purchase and consumption in overweight patients with type 2 diabetes ( T2DM ) . Methods Seventy-eight participants with T2DM being followed at Jacobi Medical Center , a large public hospital in the Bronx , New York , were r and omized to receive the st and ard of care or a 1-hour session focused on benefits of F&V consumption and $ 6 in coupons . Question naires assessed demographics , F&V intake , and farmers market purchasing at baseline and 12 weeks . Clinical parameters were obtained through chart review at baseline and at 12 weeks . Results Participants were predominantly Latino , females , and low income . At 12 weeks , there was a statistically significant increase in the number of participants in the intervention arm who reported purchasing from a farmers market . In addition , there was a minimal increase in fresh fruit intake in the intervention arm at 12 weeks . Conclusion Focused education combined with a small economic incentive result ed in an increase in purchasing behavior and fresh fruit intake per day . A more intense behavioral intervention combined with increased access may result in a significant impact on obesity and diabetes , particularly among low-income and racially diverse communities Translating evidence into clinical practice in the management of acute coronary syndromes ( ACS ) is challenging . Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes . We design ed a pragmatic , 2-arm , cluster-r and omized trial involving 34 clusters ( Brazilian public hospitals ) . Clusters were r and omized to receive a multifaceted quality improvement intervention ( experimental group ) or routine practice ( control group ) . The 6-month educational intervention included reminders , care algorithms , a case manager , and distribution of educational material s to health care providers . The primary end point was a composite of evidence -based post-ACS therapies within 24 hours of admission , with the secondary measure of major cardiovascular clinical events ( death , nonfatal myocardial infa rct ion , nonfatal cardiac arrest , and nonfatal stroke ) . Prescription of evidence -based therapies at hospital discharge were also evaluated as part of the secondary outcomes . All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling ( generalized estimating equations ) . If proven effective , this multifaceted intervention would have wide use as a means of promoting optimal use of evidence -based interventions for the management of ACS OBJECTIVE To provide up date d , evidence -based recommendations for the prevention and management of hypertension in adults . OPTIONS AND OUTCOMES For lifestyle and pharmacological interventions , evidence was review ed from r and omized controlled trials and systematic review s of trials . Changes in cardiovascular morbidity and mortality were the primary outcomes of interest . However , for lifestyle interventions , blood pressure lowering was accepted as a primary outcome given the lack of long-term morbidity and mortality data in this field . For treatment of patients with kidney disease , the progression of kidney dysfunction was also accepted as a clinical ly relevant primary outcome . EVIDENCE A Cochrane collaboration librarian conducted an independent MEDLINE search from 2005 to August 2006 to up date the 2006 Canadian Hypertension Education Program recommendations . In addition , reference lists were scanned and experts were contacted to identify additional published studies . All relevant articles were review ed and appraised independently by both content and method ological experts using prespecified levels of evidence . RECOMMENDATIONS Dietary lifestyle modifications for prevention of hypertension , in addition to a well-balanced diet , include a dietary sodium intake of less than 100 mmol/day . In hypertensive patients , the dietary sodium intake should be limited to 65 mmol/day to 100 mmol/day . Other lifestyle modifications for both normotensive and hypertensive patients include : performing 30 min to 60 min of aerobic exercise four to seven days per week ; maintaining a healthy body weight ( body mass index of 18.5 kg/m2 to 24.9 kg/m2 ) and waist circumference ( less than 102 cm in men and less than 88 cm in women ) ; limiting alcohol consumption to no more than 14 units per week in men or nine units per week in women ; following a diet reduced in saturated fat and cholesterol , and one that emphasizes fruits , vegetables and low-fat dairy products , dietary and soluble fibre , whole grains and protein from plant sources ; and considering stress management in selected individuals with hypertension . For the pharmacological management of hypertension , treatment thresholds and targets should take into account each individual 's global atherosclerotic risk , target organ damage and any comorbid conditions : blood pressure should be lowered to lower than 140/90 mmHg in all patients and lower than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease . Most patients require more than one agent to achieve these blood pressure targets . In adults without compelling indications for other agents , initial therapy should include thiazide diuretics ; other agents appropriate for first-line therapy for diastolic and /or systolic hypertension include angiotensin-converting enzyme ( ACE ) inhibitors ( except in black patients ) , long-acting calcium channel blockers ( CCBs ) , angiotensin receptor blockers ( ARBs ) or beta-blockers ( in those younger than 60 years of age ) . First-line therapy for isolated systolic hypertension includes long-acting dihydropyridine CCBs or ARBs . Certain comorbid conditions provide compelling indications for first-line use of other agents : in patients with angina , recent myocardial infa rct ion , or heart failure , beta-blockers and ACE inhibitors are recommended as first-line therapy ; in patients with cerebrovascular disease , an ACE inhibitor plus diuretic combination is preferred ; in patients with nondiabetic chronic kidney disease , ACE inhibitors are recommended ; and in patients with diabetes mellitus , ACE inhibitors or ARBs ( or , in patients without albuminuria , thiazides or dihydropyridine CCBs ) are appropriate first-line therapies . All hypertensive patients with dyslipidemia should be treated using the thresholds , targets and agents outlined in the Canadian Cardiovascular Society position statement ( recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease ) . Selected high-risk patients with hypertension who do not achieve thresholds for statin therapy according to the position paper should nonetheless receive statin therapy . Once blood pressure is controlled , acetylsalicylic acid therapy should be considered . VALIDATION All recommendations were grade d according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence -Based Recommendations Task Force . All recommendations reported here achieved at least 95 % consensus . These guidelines will continue to be up date d annually OBJECTIVE To test the effectiveness of an individualized educational intervention on knowledge , attitudes and beliefs about acute coronary syndrome ( ACS ) . METHODS This multi-site , r and omized controlled trial was conducted on 1947 patients with a diagnosis of ACS . Both groups received usual in-hospital education . Participants r and omized to the intervention group received a 40-min one to one individualized education session , delivered using motivational interviewing techniques . The intervention was reinforced 1 month and 6 months later . Knowledge , attitudes and beliefs were measured using the ACS Response Index . A total of 1136 patients ( control , n=551 ; intervention , n=585 ) completed the question naire at baseline , 3 and 12 months . Data were analyzed using repeated measures analysis of variance . Ethical approval was obtained . RESULTS There was a significant effect of the intervention on mean knowledge ( p<0.001 ) , attitude ( p=0.003 ) and belief ( p<0.001 ) scores at 3 and 12 months . CONCLUSION Ensuring patients retain information post education has always been difficult to attain . This study demonstrated that patient education using motivational interviewing techniques and an individualized approach has the potential to alter knowledge , attitudes and beliefs about ACS among a high risk population . PRACTICE IMPLICATION S This relatively short , simple and effective educational intervention could be delivered by nurses in multiple setting Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 BACKGROUND Sodium intake is high in people with type 2 diabetes ( T2DM ) . The aim of this study was to investigate whether urinary sodium excretion can be reduced by educating people with T2DM to read food labels and choose low sodium products . METHOD In a 3 month r and omised controlled trial , 78 men ( n=49 ) and women ( n=29 ) with T2DM were recruited from a Diabetes Centre at a University teaching hospital . The intervention group was educated in a single session to use the nutrition information panel on food labels to choose products which complied with the Food St and ards Australia New Zeal and ( FSANZ ) guideline of < 120 mg sodium/100 g food . The control group continued on their usual diet . The primary outcome measure was 24h urinary sodium excretion which was performed at baseline and 3 months . Data was analysed using repeated measures analysis of variance , independent sample s t-test and Pearson 's correlations . RESULTS At 3 months mean urinary sodium excretion was unchanged in the intervention ( 174±13 mmol/24 h and 175±13 mmol/24 h ) and control group ( 167±15mmol/24h and 161±13 mmol/24 h ) , and there was no between group difference ( p>0.05 ) . CONCLUSION Sodium excretion was not reduced following the label reading education provided to this group of people with T2DM Background African Americans with Type 2 diabetes ( T2DM ) have higher prevalence of diabetes , poorer metabolic control , and greater risk for complications and death compared to American Whites . Poor outcomes in African Americans with T2DM can be attributed to patient , provider , and health systems level factors . Provider and health system factors account for < 10 % of variance in major diabetes outcomes including hemoglobin A1c ( HbA1c ) , lipid control , and re source use . Key differences appear to be at the patient level . Of the patient level factors , consistent differences between African Americans and American Whites with T2DM have been found in diabetes knowledge , self-management skills , empowerment , and perceived control . A variety of interventions to improve diabetes self-management have been tested including : 1 ) knowledge interventions ; 2 ) lifestyle interventions ; 3 ) skills training interventions ; and 4 ) patient activation and empowerment interventions . Most of these interventions have been tested individually , but rarely have they been tested in combination , especially among African Americans who have the greatest burden of diabetes related complications . This study provides a unique opportunity to address this gap in the literature . Methods / Design We describe an ongoing four-year r and omized clinical trial , using a 2 × 2 factorial design , which will test the efficacy of separate and combined telephone-delivered , diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM ( HbA1c ≥ 9 % ) . Two-hundred thirty-two ( 232 ) male and female African-American participants , 18 years of age or older and with an HbA1c ≥ 9 % , will be r and omized into one of four groups for 12-weeks of phone interventions : ( 1 ) an education group , ( 2 ) a motivation/skills group , ( 3 ) a combined group or ( 4 ) a usual care/general health education group . Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control . Our primary hypothesis is that among African Americans with poorly controlled T2DM , patients r and omized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group . Discussion Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM.Trial registration National Institutes of Health Clinical Trials Registry ( Clinical Trials.gov identifier # NCT00929838 ) BACKGROUND Newly detected impaired glucose tolerance ( IGT ) or type 2 diabetes mellitus ( T2DM ) are common in patients with acute coronary syndrome ( ACS ; i.e. unstable angina/myocardial infa rct ion ) and related to disturbed beta-cell function . The aim of this study is to test the hypothesis that treatment with a dipeptidyl peptidase-4 inhibitor initiated soon after a coronary event improves beta-cell function . METHODS Acute coronary syndrome ACS patients with IGT or T2DM ( n = 71 ) , screened by oral glucose tolerance test ( OGTT ) 4 - 23 days ( median 6 days ) after hospital admission , were r and omly assigned to sitagliptin 100 mg ( n = 34 ) or placebo ( n = 37 ) and treated for a duration of 12 weeks . All patients received lifestyle advice but no glucose-lowering agents other than the study drug . The study end-point was beta-cell function assessed using the insulinogenic index ( IGI = ΔInsulin30 /ΔGlucose30 ) , derived from an OGTT , and acute insulin response to glucose ( AIRg ) assessed by a frequently sample d intravenous glucose tolerance test . RESULTS The IGI and AIRg did not differ at baseline between the sitagliptin and placebo groups ( 69.9 vs. 66.4 pmol mmol(-1 ) and 1394 vs. 1106 pmol L(-1 ) min(-1 ) respectively ) . After 12 weeks , the IGI was 85.0 in the sitagliptin and 58.1 pmol/mmol in the placebo group ( P = 0.013 ) and AIRg was 1909 and 1043 pmol L(-1 ) min(-1 ) ( P < 0.0001 ) in the sitagliptin and placebo groups respectively . Fasting glucose at baseline was 6.1 mmol L(-1 ) in sitagliptin-treated patients and 6.0 mmol L(-1 ) in those who received placebo compared with 5.8 and 5.9 mmol L(-1 ) respectively , after 12 weeks of treatment . Post load glucose metabolism improved in significantly more sitagliptin-treated patients compared with the placebo group ( P = 0.003 ) . Sitagliptin was well tolerated . CONCLUSION Sitagliptin improved beta-cell function and glucose perturbations in patients with ACS and newly diagnosed glucose disturbances OBJECTIVES Prevention of type 2 diabetes ( T2DM ) is a priority in healthcare , but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting . We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM  in people with pre-diabetes . MATERIAL S AND METHODS Forty-four general practice s were r and omised to receive either st and ard care or a 6hour group structured education programme with an annual refresher course , and regular phone contact . Participants were followed up for 3years . The primary outcome was progression to T2DM . RESULTS Eight hundred and eighty participants were included ( 36 % female , mean age 64years , 16 % ethnic minority group ) ; 131 participants developed T2DM . There was a non-significant 26 % reduced risk of developing T2DM in the intervention arm compared to st and ard care ( HR 0.74 , 95 % CI 0.48 , 1.14 , p=0.18 ) . The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant ( HR 0.65 , 0.41 , 1.03 , p=0.07 ) . There were statistically significant improvements in HbA1c ( -0.06 , -0.11 , -0.01 ) , LDL cholesterol ( -0.08 , -0.15 , -0.01 ) , sedentary time ( -26.29 , -45.26 , -7.32 ) and step count ( 498.15 , 162.10 , 834.20 ) when data were analysed across all time points . CONCLUSIONS This study suggests that a relatively low re source , pragmatic diabetes prevention programme result ed in modest benefits to biomedical , lifestyle and psychosocial outcomes , however the reduction to the risk of T2DM did not reach significance . The findings have important implication s for future research and primary care Background —Delay from onset of acute coronary syndrome ( ACS ) symptoms to hospital admission continues to be prolonged . To date , community education campaigns on the topic have had disappointing results . Therefore , we conducted a clinical r and omized trial to test whether an intervention tailored specifically for patients with ACS and delivered one-on-one would reduce prehospital delay time . Methods and Results — Participants ( n=3522 ) with documented coronary heart disease were r and omized to experimental ( n=1777 ) or control ( n=1745 ) groups . Experimental patients received education and counseling about ACS symptoms and actions required .  Patients had a mean age of 67±11 years , and 68 % were male . Over the 2 years of follow-up , 565 patients ( 16.0 % ) were admitted to an emergency department with ACS symptoms a total of 842 times . Neither median prehospital delay time ( experimental , 2.20 versus control , 2.25 hours ) nor emergency medical system use ( experimental , 63.6 % versus control , 66.9 % ) was different between groups , although experimental patients were more likely than control to call the emergency medical system if the symptoms occurred within the first 6 months following the intervention ( P=0.036 ) . Experimental patients were significantly more likely to  take aspirin after symptom onset than control patients ( experimental , 22.3 % versus control , 10.1 % , P=0.02 ) . The intervention did not result in an increase in emergency department use ( experimental , 14.6 % versus control , 17.5 % ) . Conclusions —The education and counseling intervention did not lead to reduced prehospital delay or increased ambulance use . Reducing the time from onset of ACS symptoms to arrival at the hospital continues to be a significant public health challenge . Clinical Trial Registration — clinical trials.gov . Identifier NCT00734760 AIMS To determine whether tighter cardiovascular risk factor control with structured education in individuals with type 2 diabetes ( T2DM ) and microalbuminuria benefits cardiovascular risk factors . METHODS Participants from a multiethnic population , recruited from primary care and specialist clinics were r and omised to intensive intervention with structured patient ( DESMOND model ) education ( n=94 ) or usual care by own health professional ( n=95 ) . PRIMARY OUTCOME change in HbA1c at 18months . SECONDARY OUTCOMES changes in blood pressure ( BP ) , cholesterol , albuminuria , proportion reaching risk factor targets , modelled cardiovascular risk scores . RESULTS Mean ( SD ) age and diabetes duration of participants were 61.5 ( 10.5 ) and 11.5 ( 9.3 ) years , respectively . At 18months , intensive intervention showed significant improvements in HbA1c ( 7.1(1.0 ) vs. 7.8(1.4)% , p<0.0001 ) , systolic BP ( 129(16 ) vs. 139(17 ) mmHg , p<0.0001 ) , diastolic BP ( 70(11 ) vs. 76(12 ) mmHg , p<0.001 ) , total cholesterol ( 3.7(0.8 ) vs. 4.1(0.9 ) mmol/l , p=0.001 ) . Moderate and severe hypoglycaemia was 11.2 vs. 29.0 % ; p=0.001 and 0 vs. 6.3 % ; p=0.07 , respectively . More intensive participants achieved ≥3 risk factor targets with greater reductions in cardiovascular risk scores . CONCLUSIONS Intensive intervention showed greater improvements in metabolic control and cardiovascular risk profile with lower rates of moderate and severe hypoglycaemia . Intensive glycaemic interventions should be underpinned by structured education promoting self-management in T2DM Background : Type 2 diabetes mellitus ( T2DM ) is becoming a leading problem worldwide . Emerging reports reveal alarming evidence of increasing prevalence of T2DM that has reached p and emic levels . Despite the significant incidence , there are limited reliable data re sources and comprehensive systematic review and meta- analysis on the effects of yoga on people who are a prediabetic or high risk for developing T2DM . Objective : The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the effects of yoga on people who are prediabetes or high risk of developing T2DM . Methods : The articles enrolled in the study will be retrieved from the online data bases between 2002 and the date the search es are executed . The search es will be repeated just before the final analyses and further relevant studies for inclusion . We will conduct a bibliographic search in data bases : Medline / PubMed , Scopus , Cochrane Library , EBSCO , and IndMED using keywords including prediabetes state , high risk for diabetes , metabolic syndrome , and yoga . A defined search strategy will be implemented along with selection criteria to obtain full-text articles of relevant studies . This study protocol was prepared according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis for Protocol s 2015 guidelines . There will be no language restrictions . Ethics and dissemination : The proposed study will be based on published studies and publicly available anonymized data without directly involving human participants and therefore requires neither formal human ethical review nor approval by a human research ethics committee . We published an outline of the protocol in the International Prospect i ve Register of Systematic Review s ( PROSPERO ) in 2018 . We plan to disseminate the findings of this systematic review and meta- analysis through publication in a peer- review ed journal and presentation at relevant conference proceedings . In addition , we believe the results of the systematic review will have implication s for policy and practice . We will prepare policymaker summary using a vali date d format , disseminate through social media and email discussion groups . Review registration number : PROSPERO registration number CRD CONTEXT Studies have found that patients with acute coronary syndromes ( ACS ) often do not receive evidence -based therapies in community practice . This is particularly true in low- and middle-income countries . OBJECTIVE To evaluate whether a multifaceted quality improvement ( QI ) intervention can improve the use of evidence -based therapies and reduce the incidence of major cardiovascular events among patients with ACS in a middle-income country . DESIGN , SETTING , AND PARTICIPANTS The BRIDGE-ACS ( Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes ) trial , a cluster-r and omized ( concealed allocation ) trial conducted among 34 clusters ( public hospitals ) in Brazil and enrolling a total of 1150 patients with ACS from March 15 , 2011 , through November 2 , 2011 , with follow-up through January 27 , 2012 .  INTERVENTION Multifaceted QI intervention including educational material s for clinicians , reminders , algorithms , and case manager training , vs routine practice ( control ) . MAIN OUTCOME MEASURES Primary end point was the percentage of eligible patients who received all evidence -based therapies ( aspirin , clopidogrel , anticoagulants , and statins )  during the first 24 hours in patients without contraindications . RESULTS Mean age of the patients enrolled was 62 ( SD , 13 ) years ; 68.6 % were men , and 40 % presented with ST-segment elevation myocardial infa rct ion , 35.6 % with non-ST-segment elevation myocardial infa rct ion , and 23.6 % with unstable angina . The r and omized clusters included 79.5 % teaching hospitals , all from major urban areas and 41.2 % with 24-hour percutaneous coronary intervention capabilities . Among eligible patients ( 923/1150 [ 80.3 % ] ) , 67.9 % in the intervention vs 49.5 % in the control group received all eligible acute therapies ( population average odds ratio [ OR(PA ) ] , 2.64 [ 95 % CI , 1.28 - 5.45 ] ) . Similarly , among eligible patients ( 801/1150 [ 69.7 % ] ) , those in the intervention group were more likely to receive all eligible acute and discharge medications ( 50.9 % vs 31.9 % ; OR(PA ) , , 2.49 [ 95 % CI , 1.08 - 5.74 ] ) . Overall composite adherence scores were higher in the intervention clusters ( 89 % vs 81.4 % ; mean difference , 8.6 % [ 95 % CI , 2.2%-15.0 % ] ) . In-hospital cardiovascular event rates were 5.5 % in the intervention group vs 7.0 % in the control group ( OR(PA ) , 0.72 [ 95 % CI , 0.36 - 1.43 ] ) ; 30-day all-cause mortality was 7.0 % vs 8.4 % ( ORPA , 0.79 [ 95 % CI , 0.46 - 1.34 ] ) . CONCLUSION Among patients with ACS treated in Brazil , a multifaceted educational intervention result ed in significant improvement in the use of evidence -based therapies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00958958 BACKGROUND This study aim ed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity ( PA ) and improving hemoglobin A(1c)(HbA(1c ) ) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus ( T2DM ) . METHODS Of 691 eligible sedentary patients with T2DM and the metabolic syndrome , 606 were enrolled in 22 outpatient diabetes clinics across Italy and r and omized by center , age , and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling ( exercise group ) vs counseling alone ( control group )  for 12 months . End points included HbA(1c ) level ( primary ) and other cardiovascular risk factors and coronary heart disease risk scores ( secondary ) . RESULTS The mean ( SD ) volume of PA ( metabolic equivalent hours per week ) was significantly higher ( P < .001 ) in the exercise ( total PA [ nonsupervised conditioning PA + supervised PA ] , 20.0 [ 0.9 ] , and nonsupervised , 12.4 [ 7.4 ] ) vs control ( 10.0 [ 8.7 ] ) group . Compared with the control group , supervised exercise produced significant improvements ( mean difference [ 95 % confidence interval ] ) in physical fitness ; HbA(1c ) level ( -0.30 % [ -0.49 % to -0.10 % ] ; P < .001 ) ; systolic ( -4.2 mm Hg [ -6.9 to -1.6 mm Hg ] ; P = .002 ) and diastolic ( -1.7 mm Hg [ -3.3 to -1.1 mm Hg ] ; P = .03 ) blood pressure ; high-density lipoprotein ( 3.7 mg/dL [ 2.2 to 5.3 mg/dL ] ; P < .001 ) and low-density lipoprotein ( -9.6 mg/dL [ -15.9 to -3.3 mg/dL ] ; P = .003 ) cholesterol level ; waist circumference ( -3.6 cm [ -4.4 to -2.9 cm ] ; P < .001 ) ; body mass index ; insulin resistance ; inflammation ; and risk scores . These parameters improved only marginally in controls . CONCLUSIONS This exercise intervention strategy was effective in promoting PA and improving HbA(1c ) and cardiovascular risk profile . Conversely , counseling alone , though successful in achieving the currently recommended amount of activity , was of limited efficacy on cardiovascular risk factors , suggesting the need for a larger volume of PA in these high-risk subjects . Trial Registration is rct n.org Identifier : IS RCT N04252749 AIMS To evaluate efficacy of a pathway-based quality improvement intervention on appropriate prescribing of the low molecular weight heparin , enoxaparin , in patients with varying risk categories of acute coronary syndrome ( ACS ) . METHODS Rates of enoxaparin use retrospectively evaluated before and after pathway implementation at an intervention hospital were compared to concurrent control patients at a control hospital ; both were community hospitals in south-east Queensl and . The study population was a group of r and omly selected patients ( n = 439 ) admitted to study hospitals with a discharge diagnosis of chest pain , angina , or myocardial infa rct ion , and stratified into high , intermediate , low-risk ACS or non-cardiac chest pain : 146 intervention patients ( September-November 2003 ) , 147 historical controls ( August-December 2001 ) at the intervention hospital ; 146 concurrent controls ( September-November 2003 ) at the control hospital . Interventions were active implementation of a user-modified clinical pathway coupled with an iterative education programme to medical staff versus passive distribution of a similar pathway without user modification or targeted education . Outcome measures were rates of appropriate enoxaparin use in high-risk ACS patients and rates of inappropriate use in intermediate and low-risk patients . RESULTS Appropriate use of enoxaparin in high-risk ACS patients was above 90 % in all patient groups . Inappropriate use of enoxaparin  was significantly reduced as a result of pathway use in intermediate risk ( 9 % intervention patients vs 75 % historical controls vs 45 % concurrent controls ) and low-risk patients ( 9 % vs 62 % vs 41 % ; P < 0.001 for all comparisons ) . Pathway use was associated with a 3.5-fold ( 95 % CI : 1.3 - 9.1 ; P = 0.012 ) increase in appropriate use of enoxaparin  across all patient groups . CONCLUSION Active implementation of an acute chest pain pathway combined with continuous education reduced inappropriate use of  enoxaparin  in patients presenting with intermediate or low-risk ACS BACKGROUND Intensive treatment of patients with Type 2 diabetes mellitus ( T2DM ) from the moment of diagnosis facilitates β-cell recovery . Self-monitoring of blood glucose (SMBG)-based educational and pharmacological intervention may be better than conventional HbA1c algorithms in the treatment of newly diagnosed T2DM . METHODS Newly diagnosed T2DM patients were r and omized to either an SMBG-based intervention or an  HbA1c-based control group ( n = 99 and 62 , respectively ) and were followed for 1 year . RESULTS Higher rates of diabetes regression ( HbA1c < 6 % on metformin alone ) and remission ( HbA1c between 6.0 % and 6.4 % ) were achieved in the intervention compared with the control group ( 39 % vs 5 % ( P < 0.001 ) and 37 % vs 30 % ( P < 0.01 ) , respectively ) . Furthermore , significantly greater reductions in median HbA1c ( 6.6 % to 6.1 % ; P < 0.05 ) and body mass index ( 29.6 - 27.9 kg/m(2 ) ; P < 0.001 ) were seen in the intervention over the 1 year of therapy . The percentage of patients achieving a lifestyle score > 12 was significantly greater in the SMBG compared with the control group ( 38.4 % vs 9.7 % respectively ; P < 0.001 ) . An inverse correlation was observed between SMBG and HbA1c levels ( P < 0.04 ) . CONCLUSIONS The results indicate that SMBG-based structured educational and pharmacological programs empower patients to achieve nutritional and physical activity goals , and encourage physicians and patients to use SMBG to optimize therapy . We believe that the concept of intensive treatment of T2DM patients should be modified ; instead of referring to the type of treatment ( insulin use ) , the term should reflect the intensity with which we work to reach glucose objectives IMPORTANCE Women with a history of gestational diabetes mellitus ( GDM ) are at substantially increased risk of type 2 diabetes mellitus ( T2DM ) . The identification of important modifiable factors could help prevent T2DM in this high-risk population . OBJECTIVE To examine the role of physical activity and television watching and other sedentary behaviors  , and changes in these behaviors in the progression from GDM to T2DM . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 4554 women from the Nurses ' Health Study II who had a history of GDM , as part of the ongoing Diabetes & Women 's Health Study . These women were followed up from 1991 to 2007 . EXPOSURES Physical activity and television watching and other sedentary behaviors  were assessed in 1991 , 1997 , 2001 , and 2005 . MAIN OUTCOMES AND MEASURE Incident T2DM identified through self-report and confirmed by supplemental question naires . RESULTS We documented 635 incident T2DM cases during 59,287 person-years of follow-up . Each 5-metabolic equivalent hours per week ( MET-h/wk ) increment of total physical activity , which is equivalent to 100 minutes per week of moderate-intensity physical activity , was related to a 9 % lower risk of T2DM ( adjusted relative risk [ RR ] , 0.91 ; 95 % CI , 0.88 - 0.94 ) ; this inverse association remained significant after additional adjustment for body mass index ( BMI ) . Moreover , an increase in physical activity was associated with a lower risk of developing T2DM . Compared with women who maintained their total physical activity levels , women who increased their total physical activity levels by 7.5 MET-h/wk or more ( equivalent to 150 minutes per week of moderate-intensity physical activity ) had a 47 % lower risk of T2DM ( RR , 0.53 ; 95 % CI , 0.38 - 0.75 ) ; the association remained significant after additional adjustment for BMI . The multivariable adjusted RRs ( 95 % CIs ) for T2DM associated with television watching of 0 to 5 , 6 to 10 , 11 to 20 , and 20 or more hours per week were 1 ( reference ) , 1.28 ( 1.04 - 1.59 ) , 1.41 ( 1.11 - 1.79 ) , and 1.77 ( 1.28 - 2.45 ) , respectively ( P value for trend < .001 ) ; additional adjustment for BMI attenuated the association . CONCLUSIONS AND RELEVANCE Increasing physical activity may lower the risk of progression from GDM to T2DM . These findings suggest a hopeful message to women with a history of GDM , although they are at exceptionally high risk for T2DM , promoting an active lifestyle may lower the risk AIM To evaluate the impact of diabetes education provided to patients with type 2 diabetes mellitus ( T2DM ) in non-controlled studies ( " real-world conditions " ) on quality of care , re source consumption and conditions of employment . METHODS This cross-sectional study and longitudinal follow-up describe the data ( demographic and socioeconomic profiles , clinical characteristics , treatment of hyperglycaemia and associated cardiovascular risk factors , re source consumption ) collected during the second phase ( 2006 ) of the International Diabetes Management Practice s Study ( IDMPS ) . Patients received diabetes education directly from the practice nurse , dietitian or educator , or were referred to ad hoc group-education programmes ; all programmes emphasized healthy lifestyle changes , self-care and active participation in disease control and treatment . Educated vs non-educated T2DM patients ( n=5692 in each group ) , paired by age , gender and diabetes duration , were r and omly recruited for the IDMPS by participating primary -care physicians from 27 countries in Eastern Europe , Asia , Latin America and Africa . Outcome measures included clinical ( body weight , height , waist circumference , blood pressure , foot evaluation ) , metabolic ( HbA(1c ) levels , blood lipid profile ) and biochemical control measures . Treatment goals were defined according to American Diabetes Association guidelines . RESULTS T2DM patients ' education significantly improved the percentage of patients achieving target values set by international guidelines . Educated patients increased their insulin use and self-care performance , had a lower rate of chronic complications and a modest increase in cost of care , and probably higher salaries and slightly better productivity . CONCLUSION Diabetes education is an efficient tool for improving care outcomes without having a major impact on healthcare costs Purpose The purpose of this study was to identify the breads most commonly consumed by adults with type 2 diabetes ( T2DM ) and then examine the postpr and ial glycemic , insulinemic , and appetite responses that these breads elicit . Methods One hundred people with T2DM were surveyed to identify the varieties of bread they most frequently consumed . According to a r and omized crossover design , 11 fasting participants with T2DM consumed 50 g of available carbohydrate from 4 breads .  Glucose and insulin concentrations and appetite ratings were determined over 270 minutes . Results Three commonly consumed varieties ( white , whole wheat buttermilk , whole grain ) identified in the survey — plus a lower-glycemic-index “ control ” bread ( pumpernickel rye)—were tested in the second phase . Despite perceived differences between “ brown ” and “ white ” breads , the white , whole wheat buttermilk , and wholegrain breads promoted similar glycemic and insulinemic responses .  Pumpernickel bread result ed in a significantly lower peak glucose ( P < .01 ) than all other breads and a lower peak insulin ( P < .001 ) than white or wholegrain bread . Similar appetite responses were found with all 4 breads . Conclusions Adults with T2DM are choosing a variety of breads with perceived differential effects on glycemic , insulinemic , and appetite responses . Appreciable benefits , however , are not conferred by the commonly consumed breads . If breads known to promote favorable metabolic responses are unavailable , the primary emphasis in education should be placed on portion control . Conveying this information to patients is crucial if nutrition education is to achieve its aim of empowering individuals to manage their diabetes through their food choices BACKGROUND Health consumers increasingly want access to accurate , evidence -based information about their medications . Currently , education about medications ( that is , information that is design ed to achieve health or illness related learning ) is provided predominantly via spoken communication between the health provider and consumer , sometimes supplemented with written material s. There is evidence , however , that current educational methods are not meeting consumer needs . Multimedia educational programs offer many potential advantages over traditional forms of education delivery . OBJECTIVES To assess the effects of multimedia patient education interventions about prescribed and over-the-counter medications in people of all ages , including children and carers . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL , The Cochrane Library 2011 , Issue 6 ) , MEDLINE ( 1950 to June 2011 ) , EMBASE ( 1974 to June 2011 ) , CINAHL ( 1982 to June 2011 ) , PsycINFO ( 1967 to June 2011 ) , ERIC ( 1966 to June 2011 ) , ProQuest Dissertation & Theses Data base ( to June 2011 ) and reference lists of articles . SELECTION CRITERIA R and omised controlled trials ( RCTs ) and quasi- RCTs of multimedia-based patient education about prescribed or over-the-counter medications in people of all ages , including children and carers , if the intervention had been targeted for their use . DATA COLLECTION AND ANALYSIS Two review authors independently extracted data and assessed the risk of bias of included studies . Where possible , we contacted study authors to obtain missing information . MAIN RESULTS We identified 24 studies that enrolled a total of 8112 participants . However , there was significant heterogeneity in the comparators used and the outcomes measured , which limited the ability to pool data . Many of the studies did not report sufficient information in their methods to allow judgment of their risk of bias . From the information that was reported , three of the studies had a high risk of selection bias and one was at high risk of bias due to lack of blinding of the outcome assessors . None of the included studies reported the minimum clinical ly important difference for the outcomes that were measured . We have therefore reported results from the studies but have been unable to interpret whether differences were of clinical importance .The main findings of the review are as follows . Knowledge : There is low quality evidence that  multimedia education was more effective than usual care ( non-st and ardised education provided as part of usual clinical care ) or no education ( st and ardised mean difference ( SMD ) 1.04 , 95 % confidence interval ( CI ) 0.49 to 1.58 , six studies with 817 participants ) . There was considerable statistical heterogeneity ( I(2 ) = 89 % ) , however , all but one of the studies favoured the multimedia group . There is moderate quality evidence that multimedia education was not more effective at improving knowledge than control multimedia interventions ( i.e. multimedia programs that do not provide information about the medication ) ( mean difference ( MD ) of knowledge scores 2.78 % , 95 % CI -1.48 to 7.0 , two studies with 568 participants ) . There is moderate quality evidence that multimedia education was more effective when added to a co-intervention ( written information or brief st and ardised instructions provided by a health professional ) compared with the co-intervention alone ( MD of knowledge scores 24.59 % , 95 % CI 22.34 to 26.83 , two studies with 381 participants ) .Skill acquisition : There is moderate quality evidence that  multimedia education  was more effective than usual care  or  no education  ( MD of inhaler technique score 18.32 % , 95 % CI 11.92 to 24.73 , two studies with 94 participants ) and written education ( risk ratio ( RR ) of improved inhaler technique 2.14 , 95 % CI 1.33 to 3.44 , two studies with 164 participants ) . There is very low quality evidence that  multimedia education was equally effective as education by a health professional ( MD of inhaler technique score -1.01 % , 95 % CI -15.75 to 13.72 , three studies with 130 participants ) .Compliance with medications : There is moderate quality evidence that there was no difference between  multimedia education  and usual care or no education ( RR of complying 1.02 , 95 % CI 0.96 to 1.08 , two studies with 4552 participants ) .We could not determine the effect of multimedia education on other outcomes , including patient satisfaction , self-efficacy and health outcomes , due to an inadequate number of studies from which to draw conclusions . AUTHORS ' CONCLUSIONS This review provides evidence that multimedia education about medications is more effective than usual care ( non-st and ardised education provided by health professionals as part of usual clinical care ) or no education , in improving both knowledge and skill acquisition . It also suggests that multimedia education is at least equivalent to other forms of education , including written education and education provided by a health professional . However , this finding is based on often low quality evidence from a small number of trials . Multimedia education about medications could therefore be considered as an adjunct to usual care but there is inadequate evidence to recommend it as a replacement for written education or education by a health professional . Multimedia education may be considered as an alternative to education provided by a health professional , particularly in setting s where provision of detailed education by a health professional is not feasible . More studies evaluating multimedia educational interventions are required in order to increase confidence in the estimate of effect of the intervention . Conclusions regarding the effect of multimedia education were limited by the lack of information provided by study authors about the educational interventions , and variability in their content and quality . Studies testing educational interventions should provide detailed information about the interventions and comparators . Research is required to establish a framework that is specific for the evaluation of the quality of multimedia educational programs . Conclusions were also limited by the heterogeneity in the outcomes reported and the instruments used to measure them . Research is required to identify a core set of outcomes which should be measured when evaluating patient educational interventions . Future research should use consistent , reliable and vali date d outcome measures so that comparisons can be made between studies PURPOSE The purpose of this study was to determine if a Health Coaching ( HC ) approach compared with formal health education ( HE ) result ed in better health outcomes among type II diabetes ( T2DM ) patients in improving glycaemic control and oral health , by use of clinical and subjective outcome measures . METHODS The study is part of a prospect i ve intervention among r and omly selected T2DM patients ( n = 186 ) in Istanbul , Turkey . The data analysed were clinical [ glycated haemoglobin ( HbA(1C ) ) , clinical attachment loss ( CAL ) ] and psychological measures [ tooth-brushing self efficacy ( TBSES ) ] . Data were collected initially and at the end of intervention . Participants were allocated r and omly to HC ( intervention ) ( n = 77 ) and HE  ( control ) ( n = 111 ) groups . RESULTS At baseline , there was no statistical difference between HC and HE regarding clinical and psychological measures , ( P > 0.05 ) . At post-intervention the HC group had significantly lower HBA(1C ) and CAL ( reduction : 7 % , 56 % ) than the HE group ( reduction : HbA(1C ) 0 % ; CAL 26 % ) , ( P ≤ 0.01 ) . Similarly , HC group , compared with HE group , had better TBSES ( increase : 61 % vs. 25 % ) and stress ( reduction : 16 % vs. 1 % ) , ( P ≤ 0.01 ) . Among high-risk group patients , the HC patients had significant improvements compared with the HE group ( reduction : HbA(1C ) 16 % vs. 5 % ; CAL 63 % vs. 18 % ; stress 39 % vs. 2 % ; fold increase : TBSES 6.6 vs. 3.6 ) ( P ≤ 0.01 ) . CONCLUSIONS The present findings may imply that HC has a significantly greater impact on better management of oral health and glycaemic control than HE . It is notable that the impact was more significant among high-risk group patients , thus HC may be recommended especially for high-risk group patients The prevalence of obesity and diabetes continues to rise in the US . Glucagon-like peptide-1 receptor agonist ( GLP-1RA ) is an effective treatment option for type 2 diabetes mellitus ( T2DM ) that promotes weight loss . Common and effective treatment options added to metformin therapy ( basal insulin , sulfonylureas , and pioglitazone ) contribute to weight gain , which makes the addition of GLP-1RAs advantageous . Exenatide was the first agent in this class and has recently been approved for use in combination with insulin glargine by the US Food and Drug Administration and the European Medicines Agency . Until recently , there was a lack of data examining basal insulin combined with these agents . The main purpose of this article is to review the prospect i ve interventional data on the safety and efficacy of GLP-1RAs ( exenatide , liraglutide , albiglutide , lixisenatide ) combined with basal insulin therapy in nonpregnant adults with T2DM . Data bases search ed were PubMed , Cochrane Central Register of Controlled Trials and the Data base of Systematic Review s ( inception to January 2012 ) . Abstract s presented at relevant diabetes and endocrine meetings from 2009 to 2011 were also review ed , as were reference lists of identified publications . A total of five studies met the criteria and were included in the review . Data from these studies demonstrated that this combination therapy offers advantages for the treatment of diabetes , such as additional lowering of A1c without major risk for hypoglycemia , lower basal insulin requirements , decreased postpr and ial glucose levels ( with or without fasting plasma glucose decreases ) , and weight loss , or at the very least , less weight gain . However , the gastrointestinal side effects and high cost of these agents may limit their use . This review demonstrates that adding a GLP-1RA to an existing basal insulin regimen is a reasonable treatment strategy in nonpregnant adult patients with T2DM Background Mobile technologies for health ( mHealth ) represent a promising strategy for reducing  type 2 diabetes ( T2DM ) risk  . The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM . Objective This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility . Methods We used a modified mHealth development framework with four phases : ( 1 ) conceptualization of the follow-on support program using theory and evidence , ( 2 ) formative research including focus groups ( n=15 , ages 39 - 79 years ) , ( 3 ) pre-testing focus groups using a think aloud protocol  ( n=20 , ages 52 - 78 years ) , and ( 4 ) piloting ( n=11 ) . Analysis was informed by the constant comparative approach , with findings from each phase informing subsequent phases . Results The first three phases informed the structure , nature , and content of the follow-on support program , including the frequency of text messages , the need for tailored content and two-way interaction , the importance of motivational messages based on encouragement and reinforcement of affective benefits ( eg , enjoyment ) with minimal messages about weight and T2DM risk , and the need for appropriate language . The refined program is personalized and tailored to the individual ’s perceived confidence , previous activity levels , and physical activity goals . The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults . Conclusions We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences , views , and needs of people at high diabetes risk . A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 83465245 ; http://www.controlled-trials.com/IS RCT N83465245/83465245 ( Archived by WebCite at http://www.webcitation.org/6dfSmrVAe Background Women who are diagnosed with gestational diabetes mellitus ( GDM ) are at increased risk for developing prediabetes and type 2 diabetes mellitus ( T2DM ) . To date , there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM . This paper describes the rationale , design and methodology of a 2-year , r and omized , controlled study being conducted in North Carolina . Methods / Design Using a two-group , repeated measures , experimental design , we will test a 14- week intensive intervention on the benefits of breastfeeding , underst and ing gestational diabetes and risk of progression to prediabetes and T2DM , nutrition and exercise education , coping skills training , physical activity ( Phase I ) , educational and motivational text messaging and 3 months of continued monthly contact ( Phase II ) . A total of 100 African American , non-Hispanic white , and bilingual Hispanic women between 22–36 weeks of pregnancy who are diagnosed with GDM and their infants will be r and omized to either the experimental group or the wait-listed control group . The first aim of the study is to determine the feasibility of the intervention . The second aim of study is to test the effects of the intervention on maternal outcomes from baseline ( 22–36 weeks pregnant ) to 10 months postpartum . Primary maternal outcomes will include fasting blood glucose and weight ( BMI ) from baseline to 10 months postpartum . Secondary maternal outcomes will include clinical , adiposity , health behaviors and self-efficacy outcomes from baseline to 10 months postpartum . The third aim of the study is to quantify the effects of the intervention on infant feeding and growth . Infant outcomes will include weight status and breastfeeding from birth through 10 months of age . Data analysis will include general linear mixed-effects models . Safety endpoints include adverse event reporting . Discussion Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory , reducing the burden of metabolic disease across two generations . Trial registration Reduced coronary flow reserve ( CFR ) , an indicator of coronary microvascular dysfunction , is seen in type 2 diabetes mellitus ( T2DM ) and predicts cardiac mortality . Since aldosterone plays a key role in vascular injury , the aim of this study was to determine whether mineralocorticoid receptor ( MR ) blockade improves CFR in individuals with T2DM . Sixty-four men and women with well-controlled diabetes on chronic ACE inhibition ( enalapril 20 mg/day )  were r and omized to add-on therapy of spironolactone 25 mg , hydrochlorothiazide ( HCTZ ) 12.5 mg , or placebo for 6 months . CFR was assessed by cardiac positron emission tomography at baseline and at the end of treatment . There were significant and similar decreases in systolic blood pressure with spironolactone and HCTZ but not with placebo . CFR improved with treatment in the spironolactone group as compared with the HCTZ group and with the combined HCTZ and placebo groups . The increase in CFR with  spironolactone  remained significant after controlling for baseline CFR , change in BMI , race , and statin use . Treatment with spironolactone improved coronary microvascular function , raising the possibility that MR blockade could have beneficial effects in preventing cardiovascular disease in patients with T2DM Executive summary Background As a chronic condition , the prevalence of Type 2 diabetes is increasing worldwide and adherence to oral medications , an essential component of self‐management , has been shown to improve glycaemic control . However compliance with oral medication adherence remains poor . Educating people with Type 2 diabetes is an important strategy to enhance self‐management ability , including medication‐taking behaviour . Objectives The overall objective of the review was to determine the effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes . Inclusion criteria Types of participants Studies involving adults over 18 years old with Type 2 diabetes , with or without co‐morbidities , currently taking oral hypoglycaemic medication without insulin treatment , and with aglycated haemoglobin ( HbA1c ) > 7.0 % prior to the intervention were considered . Aglycated haemoglobin ( HbA1c ) concentration of less than 7.0 % , is important in order to delay or prevent diabetes‐related complications . Participants could be from the primary , tertiary or acute care setting . Types of intervention The review focused on various forms of educational interventions delivered by healthcare professionals aim ed at improving participants ’ knowledge . Types of outcomes The review evaluated outcomes measuring oral hypoglycaemic adherence including HbA1c , fasting blood glucose levels and other relevant indicators . Types of studies Studies that were r and omized controlled trials ( RCTs ) or case‐control studies were considered . Search strategy A three‐stage search strategy was employed . Papers in English and between the years 1990‐2009 were search ed in the following data bases : CINAHL , Medline , Mosby 's Nursing Consult , PsycINFO , PubMed , ScienceDirect , Scopus , TRIP and Web of Science . Full text was retrieved when the titles and abstract s of studies fulfilled the inclusion criteria . Method ological quality Full papers were assessed for method ological quality independently by two review ers using critical appraisal checklists from the Joanna Briggs Institute ( JBI ) . A third review er was consulted whenever there were disagreements between the two review ers . Data collection / extraction Details of each study included in the review were extracted using st and ardized data extraction forms developed by JBI . Extraction was conducted independently by two review ers . Data synthesis Meta‐ analysis was not possible due to method ological and statistical heterogeneity of the included studies . Hence study findings are presented in narrative form . Results Seven studies included in the final review consisted of seven RCTs . Five studies concluded that the educational intervention was effective in promoting oral hypoglycaemic adherence compared to usual care . These included pharmacist‐led interventions , individual diabetes education provided by nurses and diabetes group education based on a self‐management approach . Similarities among these interventions were provision of information on oral hypoglycaemic medication and the need for regular education sessions . However , small sample s in some studies limited generalization of results . Conclusions Implication s for practice Increased knowledge of oral hypoglycaemic issues and reinforcement of the importance of medication adherence were useful in promoting adherence . Regular education sessions allow individuals to reinforce information and educators to identify barriers to medication adherence . Educational interventions focusing on self‐management strategies appear more likely to achieve positive outcomes . Implication s for research Further trials involving larger sample s and population s with poor glycaemic control are needed . The effects of educational interventions , influence of additional take‐home written material , the optimal interval length of follow‐up and duration of education sessions , and specific processes of individual or group education which have been identified as effective need further exploration BACKGROUND The Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome ( JAPAN-ACS ) trial has found that early aggressive statin therapy in patients with acute coronary syndrome ( ACS ) significantly reduces the plaque volume ( PV ) of non-culprit coronary lesions . The purpose of the present study was to evaluate clinical factors that have an impact on plaque regression using statin therapy . METHODS AND RESULTS Serial intravascular ultrasound observations over 8 - 12 months were performed in 252 ACS patients receiving pitavastatin or atorvastatin .  Linear regression analysis identified the presence of diabetes mellitus ( DM ) and PV at baseline as inhibiting factors , and serum remnant-like particle-cholesterol level at baseline as a significant factor significantly affecting the degree of plaque regression . Significant correlation between % change of PV and low-density lipoprotein cholesterol ( LDL-C ) level was found in patients with DM ( n=73 , P<0.05 , r=0.4 ) , whereas there was no significant correlation between the 2 parameters in patients without DM ( n=178 ) . CONCLUSIONS The regression of coronary plaque induced by statin therapy after ACS was weaker in diabetic patients than their counterparts . Moreover , vigorous reduction of the LDL-C levels might induce a greater degree of plaque regression in ACS patients with DM Background Weight reduction limits disease progression in obese people with coronary heart disease ( CHD ) and /or type 2 diabetes mellitus ( T2DM ) . Purpose To test a 16-week group-based weight reduction intervention combining exercise , diet and behaviour change strategies aim ed to increase self-efficacy  ( Healthy Eating and Exercise Lifestyle Program — HEELP ) on weight , body mass index ( BMI ) , waist circumference and exercise . Methods Participants with CHD and /or T2DM and BMI between 27 to 39 kg/m2 were r and omised to HEELP  ( n = 83 ) or usual care ( n = 65 ) . Results Participants were aged a mean 63.47 years ( SD 8.9 ) , male ( 58 % ) and Caucasian ( 79 % ) . HEELP participants lost significantly more weight , BMI and waist circumference and exercised more days/week for a longer duration /week than usual care . Clinical ly significant weight loss ( ≥5 % ) was more common in HEELP than usual care . Conclusion The HEELP result ed in weight loss and improved exercise behaviour in obese people with CHD and T2DM [ Purpose ] While recent studies have reported that cardiac rehabilitation is an effective treatment , there have been few studies of its effects in rehabilitation for acute coronary syndrome ( ACS ) . Therefore , the purpose of this study was to identify the effects of a home-based exercise training using a wireless electrocardiogram ( ECG ) monitoring device on ACS patients . [ Subjects ] Fifty ACS patients were r and omly divided into a experimental group of 25 patients and a control group of 25 patients . [ Methods ] The experimental group received education on the training before discharge from hospital and started home-based exercise training two weeks after discharge from hospital . The control group received conventional treatments . The left ventricular function was measured in both groups before the intervention at and 12 weeks , at the end of the intervention . [ Results ] Both the experimental group and the control group showed significant improvements in the left ventricular ejection fraction and number of regional wall motion abnormalities . In the comparison of the two groups , the experimental group showed a significantly greater decline in regional wall motion abnormalities than the control group . [ Conclusion ] Home-based exercise training implemented with a wireless monitoring device was effective at improving the left ventricular function of ACS patients Background Falls can have a considerable impact on a patients ' well being , they can result in serious physical and emotional injury , poor quality of life and increased length of hospital stay . Most of the current literature recommends a comprehensive approach to fall prevention that addresses a wide variety of risk factors and involves the use of risk assessment . Objective The objective of this review was to present the best available evidence for the effectiveness of interventions design ed to reduce the incidence of falls in older adult patients in acute care hospitals . Inclusion Criteria Types of Studies Only r and omised controlled trials ( RCTs ) assessing the effectiveness of risk assessment or other interventions that aim ed to minimise the number of falls were included . Types of Participants Participants were older adult in patients ( defined as aged 65 years or over ) in acute care hospitals . Types of Interventions This review focused on interventions design ed to assess the risk of falling or those used to minimise the risk of falling in older adult hospital patients . These interventions were compared to either st and ard practice , which included any method or technique already in place at the facility , or no intervention . Types of Outcome measures The primary outcome was the number of patient falls during hospitalisation . Search Strategy A search for published and unpublished literature from 1998 to 2008 published in the English language was conducted using all major electronic data bases . A three‐step search strategy was developed using MeSH terminology and keywords to ensure that all material relevant to the review was captured . Assessment of Quality The method ological quality of included studies was assessed by two review ers , who appraised each study independently , using st and ardised Joanna Briggs Institute ( JBI ) critical appraisal tools Data Collection and Analysis Data was extracted from the studies that were identified as meeting the criteria for method ological quality using the st and ard JBI data extraction tools . Due to the heterogeneity of population s and interventions , meta‐analyses were not possible and results are presented in narrative form . Results and Conclusions Seven studies were included in the review . The evidence on interventions for reducing the number of falls in older adults during their stay in an acute health care facility is sparse . There is some evidence to suggest that certain multifactorial interventions are more effective than others and that increasing patient education or targeting fall risk factors may be of benefit . Further high quality research is needed in order to ascertain effective fall prevention strategies in acute care facilities . Implication s for Practice There are some evidence to suggest that implementing the following interventions in acute hospitals may be effective in reducing the amount of falls of older adult in patients : ˙ a multidisciplinary multifactorial intervention program consisting of a falls risk alert card , an exercise program , an education program and the use of hip protectors after approximately 45 days ˙ a one‐on‐one patient education package entailing information on risk factors and preventative strategies for falls as well as goal setting ˙ a targeted falls risk factor reduction intervention that includes a falls risk factor screen , recommended interventions encompassing local advice and a summary of the evidence There is some evidence to suggest that implementing a multidisciplinary multifactorial intervention that consists of systematic assessment and treatment of fall risk factors , as well as active management of postoperative complications can reduce the amount of falls in patients with femoral neck fracture following surgery . Implication s for Research Better design ed RCTs that distinguish subgroups of population s ( for example people with or without cognitive impairment ) and that targets interventions at specific groups is required . Further research that focuses on individual intervention components that are part of larger multifactorial interventions are also warranted BACKGROUND African American ( AA ) women with Type 2 diabetes mellitus ( T2DM ) in the rural south experience less weight loss and poorer glycemic control in traditional diabetes management programs compared to Caucasians . This paper describes the design , rationale , and baseline characteristics from an innovative community health worker ( CHW ) delivered intervention program in this population . METHODS / DESIGN This prospect i ve trial r and omized rural AA women with uncontrolled T2DM ( HbA1c ≥ 7.0 ) to receive a behaviorally-centered , culturally-tailored lifestyle intervention during 16 contacts  from a trained AA CHW or 16 approved diabetes educational mailings . Changes from baseline in glycosylated hemoglobin levels ( HbA1c ) , blood pressure ( BP ) , weight , body mass index ( BMI ) , self-reported dietary and physical activity patterns , and psychosocial measures including diabetes distress , empowerment , depression , self-care , medication adherence , and life satisfaction will be assessed at 6- and 12-months . BASELINE RESULTS Two hundred AA women ( mean age = 53.09 ± 10.89 years ) with T2DM from impoverished rural communities were enrolled . Baseline data demonstrated profoundly uncontrolled diabetes of long term duration ( mean HbA1c = 9.11 ± 1.82 ; mean BMI = 37.68 ± 8.20 ; mean BP = 134.51 ± 20.39/84.19 ± 11.68 ; 10.5 ± 0.7 years ) . Self-care behavior assessment revealed poor dietary and medication adherence and sedentary lifestyle . Most psychosocial measures ranged within normal limits . CONCLUSION The present sample of AA women from impoverished rural communities exhibited significantly uncontrolled T2DM of long duration with associated obesity and poor lifestyle behaviors . An innovative CHW led lifestyle intervention may lead to more effective strategies for T2DM management in this population IMPORTANCE Persons with type 2 diabetes mellitus ( T2DM ) are at increased risk for decline in cognitive function , reduced brain volume , and increased white matter lesions in the brain . Poor control of blood pressure ( BP ) and lipid levels are risk factors for T2DM-related cognitive decline , but the effect of intensive treatment on brain function and structure is unknown . OBJECTIVE To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume ( TBV ) in patients with T2DM . DESIGN , SETTING , AND PARTICIPANTS A North American multicenter clinical trial including 2977 participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A1c ( HbA1c ) levels less than 7.5 % r and omized to a systolic BP goal of less than 120 vs less than 140 mm Hg ( n = 1439 ) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than 100 mg/dL ( n = 1538 ) . Participants were recruited from August 1 , 2003 , through October 31 , 2005 , with the final follow-up visit by June 30 , 2009 . MAIN OUTCOME MEASURES Cognition was assessed at baseline and 20 and 40 months . A subset of 503 participants underwent baseline and 40-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health . RESULTS Baseline mean HbA1c level was 8.3 % ; mean age , 62 years ; and mean duration of T2DM , 10 years . At 40 months , no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial . At 40 months , TBV had declined more in the intensive vs st and ard BP-lowering group ( difference , -4.4 [ 95 % CI , -7.8 to -1.1 ] cm(3 ) ; P = .01 ) . Fibrate therapy had no effect on TBV compared with placebo . CONCLUSIONS AND RELEVANCE In participants with long-st and ing T2DM and at high risk for cardiovascular events , intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at 40 months of follow-up . Intensive BP control was associated with greater decline in TBV at 40 months relative to st and ard therapy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000620 IMPORTANCE No therapy directed against diabetes has been shown to unequivocally reduce the excess risk of cardiovascular complications . Aleglitazar is a dual agonist of peroxisome proliferator-activated receptors with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles . OBJECTIVE To determine whether the addition of aleglitazar to st and ard medical therapy reduces cardiovascular morbidity and mortality among patients with type 2 diabetes mellitus and a recent acute coronary syndrome ( ACS ) . DESIGN , SETTING , AND PARTICIPANTS AleCardio was a phase 3 , multicenter , r and omized , double-blind , placebo-controlled trial conducted in 720 hospitals in 26 countries throughout North America , Latin America , Europe , and Asia-Pacific regions . The enrollment of 7226 patients hospitalized for ACS ( myocardial infa rct ion or unstable angina ) with type 2 diabetes occurred between February 2010 and May 2012 ; treatment was planned to continue until patients were followed-up for at least 2.5 years and 950 primary end point events were positively adjudicated . INTERVENTIONS R and omized in a 1:1 ratio to receive aleglitazar 150 µg or placebo daily . MAIN OUTCOMES AND MEASURES The primary efficacy end point was time to cardiovascular death , nonfatal myocardial infa rct ion , or nonfatal stroke . Principal safety end points were hospitalization due to heart failure and changes in renal function . RESULTS The trial was terminated on July 2 , 2013 , after a median follow-up of 104 weeks , upon recommendation of the data and safety monitoring board due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points . A total of 3.1 % of patients were lost to follow-up and 3.2 % of patients withdrew consent . The primary end point occurred in 344 patients ( 9.5 % ) in the aleglitazar group and 360 patients ( 10.0 % ) in the placebo group ( hazard ratio , 0.96 [ 95 % CI , 0.83 - 1.11 ] ; P = .57 ) . Rates of serious adverse events , including heart failure ( 3.4 % for aleglitazar vs 2.8 % for placebo , P = .14 ) , gastrointestinal hemorrhages ( 2.4 % for aleglitazar vs 1.7 % for placebo , P = .03 ) , and renal dysfunction ( 7.4 % for aleglitazar vs 2.7 % for placebo , P < .001 ) were increased . CONCLUSIONS AND RELEVANCE Among patients with type 2 diabetes and recent ACS , use of aleglitazar did not reduce the risk of cardiovascular outcomes . These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01042769 Background Prevention of  type 2 diabetes mellitus  ( T2DM ) is a global priority . Let ’s Prevent Diabetes is a group-based diabetes prevention programme ; it was evaluated in a cluster-r and omised trial , in which the primary analysis showed a reduction in T2DM ( hazard ratio [ HR ] 0.74 , 95 % CI 0.48–1.14 , p = 0.18 ) . We examined the association of engagement and retention with the Let ’s Prevent Diabetes prevention programme and T2DM incidence . Methods and Findings We used data from a completed cluster-r and omised controlled trial including 43 general practice s r and omised to receive either st and ard care or a 6-h group structured education programme with an annual refresher course for 2 y. The primary outcome was progression to T2DM at 3 y. The characteristics of those who attended the initial education session ( engagers ) versus nonengagers and those who attended all sessions ( retainers ) versus nonretainers were compared . Risk reduction of progression to T2DM by level of attendance was compared to st and ard care . Eight hundred and eighty participants were recruited , with 447 to the intervention arm , of which 346 ( 77.4 % ) were engagers and 130 ( 29.1 % ) were retainers . Retainers and engagers were more likely to be older , leaner , and nonsmokers than nonretainers/nonengagers . Engagers were also more likely to be male and be from less socioeconomically deprived areas than nonengagers . Participants who attended the initial session and at least one refresher session were less likely to develop T2DM compared to those in the control arm ( 30 people of 248 versus 67 people of 433 , HR 0.38 [ 95 % CI 0.24–0.62 ] ) . Participants who were retained in the programme were also less likely to develop T2DM compared to those in the control arm ( 7 people of 130 versus 67 people of 433 , HR 0.12 [ 95 % CI 0.05–0.28 ] ) . Being retained in the programme was also associated with improvements in glucose , glycated haemoglobin ( HbA1c ) , weight , waist circumference , anxiety , quality of life , and daily step count . Given that the data used are from a clinical trial , those taking part might reflect a more motivated sample than the population , which should be taken into account when interpreting the results . Conclusions This study suggests that being retained/engaged in a relatively low-re source , pragmatic diabetes prevention programme for those at high risk is associated with reductions in the progression to T2DM in comparison to those who receive st and ard care . Nonengagers and nonretainers share similar high-risk traits . Service providers of programmes should focus on reaching these hard-to-reach groups . Trial Registration Clinical Trials.gov IS RCT Background Health education is considered to be essential in the overall care of patients with type 2 diabetes mellitus ( T2DM ) ;  systematic health education integrates individual education not only during hospitalization but also extended care outside of a hospital . To test effectiveness of the systematic health education model for T2DM , we conducted a r and omized study with a control group among patients with T2DM living in Nanjing , China . Methods 998 eligible patients completed the enrollment and were r and omized to systematic health education model and conventional model groups ( 498 and 500 patients , resp . ) . The systematic health education model was based on the following aspects : image education , visitation of the exhibition hall , dissemination of educational material s , individualized medical nutrition therapy and exercise programs , WeChat group and regular health lectures , evaluation of complications , lifestyle modification , systematic treatment scheme , self-monitoring of glycemic control , monthly evaluation of the therapeutic effect , proposed improvement measures , and individualized follow-up scheme . The main outcome measures were glycated hemoglobin A1c ( HbA1c ) , blood pressure , body mass index ( BMI ) , and lipids during the 2-year follow-up . Results The systematic health education model led to a favorable variation in HbA1c , LDL cholesterol , and systolic blood pressure ( SBP ) ( P < 0.05 ) . After adjusted analysis , the HbA1c decreased by 0.67 % ( P < 0.01 ) in the systematic health education model , SBP decreased by 10.83 mmHg ( P < 0.01 ) , and the level of diastolic blood pressure ( DBP ) , HDL cholesterol , and total cholesterol decreased slightly and was not significant . The BMI did not change significantly during the study in either of the two groups . Conclusions The systematic health education model is a useful method in the treatment of T2DM because it contributes to decrease in HbA1c , LDL cholesterol , and SBP levels , as well as helps in increasing the compliance with the control criteria , except for DBP and BMI Background Type 2 Diabetes Mellitus ( T2DM ) is common , affecting nearly 400 million people worldwide . Achieving good health for people with T2DM requires active self-management ; however , uptake of self-management education is poor , and there is an urgent need to find better , more acceptable , cost-effective methods of providing self-management support . Web-based self-management support has many potential benefits for patients and health services . The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM . Methods This will be a multi-centre individually r and omised controlled trial in primary care , recruiting adults with T2DM who are registered with participating general practice s in Engl and . Participants will be r and omised to receive either an evidence -based , theoretically informed , web-based self-management programme for people with T2DM which addresses medical , emotional , and role management , called Healthy Living for People with type 2 Diabetes ( HeLP-Diabetes ) or a simple information website . The joint primary outcomes are glycated haemoglobin ( HbA1c ) and diabetes-related distress , measured by the Problem Areas In Diabetes ( PAID ) question naire . Secondary outcomes include cardiovascular risk factors , depression and anxiety , and self-efficacy for self-management of diabetes . Health economic data include health service use , costs due to the intervention , and EQ-5D for calculation of Quality Adjusted Life Years ( QALYS ) . Data will be collected at baseline , 3 months and 12 months , with the primary endpoint at 12 months . Practice nurses , blinded to patient allocation , collect clinical data ; patients complete online question naires for patient reported measures . A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c ( both small effect sizes ) . The analysis will follow a pre-specified analysis plan , based on comparing the groups as r and omised ( intention-to-treat ) . Discussion The findings of this trial are likely to be of interest to policy makers , clinicians , and commissioners , all of whom are actively seeking additional forms of self-management support for people with T2DM.Trial registration The Trial Registration number is IS RCT N02123133 ; date of registration 14.2.13 OBJECTIVE Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus ( T2DM ) . The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM . STUDY DESIGN A pilot r and omized , controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy . The primary outcome was glycemic control measured with hemoglobin A1c < 7 % at delivery . Maternal and neonatal outcomes were compared between groups . RESULTS In this study , 8 women received metformin and 11 received insulin .  All women in both groups achieved glycemic control by delivery ( HgbA1c : metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92 % ) . There were similar rates of cesarean delivery , birth weights , neonatal intensive care unit admissions , respiratory distress syndrome , and neonatal dextrose treatment between groups . There was one case of fetal macrosomia in the insulin group , one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy . CONCLUSION In this pilot study , glycemic control was achieved in women who received metformin and insulin . Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM BACKGROUND & AIMS The usefulness of low-carbohydrate diet ( LCD ) for Japanese patients with type 2 diabetes mellitus ( T2DM ) has not been fully investigated . Therefore , we compared the effectiveness and safety of LCD with calorie restricted diet ( CRD ) . METHODS This prospect i ve , r and omized , open-label , comparative study included 66 T2DM patients with HbA1c > 7.5 % even after receiving repeated education programs on CRD .  They were r and omly allocated to either the 130g/day LCD group ( n = 33 ) or CRD group ( n = 33 ) . Patients received personal nutrition education of CRD or LCD for 30 min at baseline , 1 , 2 , 4 , and 6 months . Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients ( 28 × ideal body weight calories per day ) . Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions . Several parameters were assessed at baseline and 6 months after each intervention . The primary endpoint was a change in HbA1c level from baseline to the end of the study . RESULTS At baseline , BMI and HbA1c were 26.5 ( 24.6 - 30.1 ) and 8.3 ( 8.0 - 9.3 ) , and 26.7 ( 25.0 - 30.0 ) kg/m2 and 8.0 ( 7.6 - 8.9 ) % , in the CRD and LCD , respectively . At the end of the study , HbA1c decreased by -0.65 ( -1.53 to -0.10 ) % in the LCD group , compared with 0.00 ( -0.68 to 0.40 ) % in the CRD group ( p < 0.01 ) . Also , the decrease in BMI in the LCD group [ -0.58 ( -1.51 to -0.16 ) kg/m2 ] exceeded that observed in the CRD group ( p = 0.03 ) . CONCLUSIONS Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM . LCD is a potentially useful nutrition therapy for Japanese patients who can not adhere to CRD . This trial was registered at http://www.umin.ac.jp/english/ ( University Hospital Medical Information Network : study ID number 000010663 ) This study was design ed to evaluate how new treatment guidelines of acute coronary syndrome ( ACS ) without ST elevation have been implemented in clinical practice especially in diabetic patients . A prospect i ve follow-up was performed on 501 consecutive patients with suspected ACS without ST elevation admitted to nine hospitals in Finl and between 15 January and 11 March 2001 . The study group included 143 ( 29 % ) diabetic patients . Their risk profile was more severe than in non-diabetic patients ; ST-depression on admission electrocardiography 57 versus 38 % ; P<0.0001 , elevated troponin levels 66 versus 56 % ; P<0.05 . Six months composite incidence of death , new myocardial infa rct ion ( MI ) , refractory angina or readmission for unstable angina was 39 % in diabetic patients and 20 % in non-diabetic patients ( P<0.0001 ) . In spite of this more severe risk profile , glycoprotein ( GP ) IIb/IIIa receptor antagonists and statins were used with similar frequency in non-diabetic and diabetic patients ( 15 vs. 19 and 48 vs. 54 % , respectively ; P = NS for both ) . In diabetic patients mean delay for in hospital coronary angiography was longer ( 6.4 vs. 4.2 days , P<0.05 ) and it was performed less often ( 32 vs. 45 % P<0.05 ) . Our results show that diabetic patients with ACS have higher risk profile and worse outcome than non-diabetic patients . Despite their indisputable benefits in diabetic patients , statins , GP IIb/IIIa receptor antagonists and invasive strategy were underused or often neglected . Further education is needed to change attitudes and to better implement new guidelines into clinical practice OBJECTIVE Plasma resistin level is a potential molecular link between obesity and diabetes . Causal role of resistin , type 2 diabetes mellitus ( T2DM ) and genetic variants have not been thoroughly investigated . Therefore , we conducted a genome-wide association study ( GWAS ) to identify quantitative trait loci associated with resistin levels and investigated whether these variants were prospect ively associated with the development of metabolic syndrome ( MetS ) and T2DM in an independent community-based cohort , the CardioVascular Disease risk FACtors Two-township Study ( CVDFACTS ) . RESEARCH DESIGN AND METHODS We genotyped 382 young-onset hypertensive ( YOH ) subjects with Illumina HumanHap550 chips and search ed for quantitative trait loci ( QTLs ) of resistin in the 1(st ) stage GWAS and confirmed the finding in another 559 YOH subjects . Logistic regression was used to examine the Mendelian r and omization effects between genotypes of confirmed QTLs and metabolic outcomes in 3400 subjects of CVDFACTS . RESULTS Two single nucleotide polymorphisms ( SNP ) ( rs3745367 and rs1423096 ) were significantly associated with resistin levels ( p = 5.52 × 10(-15 ) and p = 2.54 × 10(-20 ) ) and replicated in another 559 YOH subjects ( p = 1.29 × 10(-3 ) and p = 1.13 × 10(-7 ) ) , respectively . The SNP rs1423096 was further associated with the levels of HDL-C ( p = 0.006 ) , the risk of MetS ( OR = 2.21 , p = 0.0034 ) and T2DM ( OR = 1.62 , p = 0.0063 ) in the CVDFACTS . People with the haplotypes A-G and G-G determined by rs3745367 and rs1423096 showed a significantly increased T2DM risk ( p = 0.0068 and p = 0.0035 , respectively ) compared with those with A-A haplotype . CONCLUSION We have found that rs3745367 and rs1423096 on the RETN gene were significantly associated with resistin levels . However , rs1423096 , downstream of RETN , seems to be associated with MetS and T2DM risk more so than rs3745367 . The established genotype-disease association points to a causal association of resistin and T2DM BACKGROUND The recent North American and European practice guidelines in patients with non-ST-segment elevation acute coronary syndrome ( nSTE ACS ) recommend glycoprotein IIb/IIIa ( GpIIb-IIIa ) inhibition in patients undergoing an early invasive treatment strategy . However , the guidelines are not explicit regarding the timing of initiation of GpIIb-IIIa antagonists , and there is marked variation in clinical practice regarding their use . STUDY DESIGN The EARLY ACS trial will enroll 10,500 patients in a prospect i ve , r and omized , double blind , international , multicenter investigation of early eptifibatide compared with placebo ( with provisional eptifibatide in the catheterization laboratory ) in patients with high-risk nSTE ACS in whom an invasive strategy is planned no sooner than the next calendar day . The primary efficacy end point is the 96-hour composite of all-cause mortality , nonfatal myocardial infa rct ion , recurrent ischemia requiring urgent revascularization , or need for thrombotic bailout with GpIIb-IIIa inhibitor during percutaneous coronary intervention . The key secondary end point is the composite of death or nonfatal myocardial infa rct ion within 30 days of enrollment . IMPLICATION S The EARLY ACS trial will be the largest study to date to evaluate the utility of early GpIIb-IIIa inhibition in patients with nSTE ACS in whom an invasive approach is planned . This trial will provide important evidence regarding the benefit of initiating eptifibatide early after presentation with high-risk ACS versus delayed provisional use after coronary angiography . Furthermore , it will explore the ability of biomarkers to identify high-risk patients who may benefit from such an early aggressive approach Inadequate knowledge of the influence of lifestyle on clinical outcomes contributes to the difficulties many African Americans experience with type 2 diabetes mellitus ( T2DM ) . This pilot study examined a 12-week church-based culturally targeted diabetes self-management education ( DSME ) intervention for middle-aged and older African Americans with T2DM . Quantitative data were collected at baseline and at 12 weeks and included question naires and anthropometric measures . There were significant increases in medication adherence ( p = .006 ) , healthy eating ( p = .009 ) , and foot care adherence ( p = .003 ) . The intervention had a clinical ly significant effect on systolic blood pressure , blood lipids , physical activity , and waist circumference . Church-based culturally targeted DSME interventions may result in improved outcomes for African-American adults with T2DM . The authors discuss the value of community-based interventions that target behavioural changes in population s of chronically ill patients , particularly those who historically have been disenfranchised and /or underserved Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT Background There are well-documented treatment gaps in secondary prevention of coronary heart disease and no clear guidelines to assist early physical activity after acute coronary syndromes ( ACS ) . Smartphone technology may provide an innovative platform to close these gaps . This paper describes the study design of a r and omized controlled trial assessing whether a smartphone-based secondary prevention program can facilitate early physical activity and improve cardiovascular health in patients with ACS . Methods We have developed a multi-faceted , patient-centred smartphone-based secondary prevention program emphasizing early physical activity with a graduated walking program initiated on discharge from ACS admission . The program incorporates ; physical activity tracking through the smartphone ’s accelerometer with interactive feedback and goal setting ; a dynamic dashboard to review and optimize cardiovascular risk factors ; educational messages delivered twice weekly ; a photographic food diary ; pharmacotherapy review ; and support through a short message service . The primary endpoint of the trial is change in exercise capacity , as measured by the change in six-minute walk test distance at 8-weeks when compared to baseline . Secondary endpoints include improvements in cardiovascular risk factor status , psychological well-being and quality of life , medication adherence , uptake of cardiac rehabilitation and re-hospitalizations . Discussion This r and omized controlled trial will use a smartphone-phone based secondary prevention program to emphasize early physical activity post-ACS . It will provide evidence regarding the feasibility and utility of this innovative platform in closing the treatment gaps in secondary prevention . Trial registration The trial was retrospectively registered in the Australian New Zeal and Clinical Trials Registry ( ANZCTR ) on April 4 , 2016 . The registration number is ACTRN12616000426482 IMPORTANCE Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus ( T2DM ) . OBJECTIVE To compare the remission of T2DM following surgical and nonsurgical treatments . DESIGN , SETTING , AND PARTICIPANTS In this 3-arm r and omized clinical trial conducted at the University of Pittsburgh Medical Center from October 1 , 2009 , to June 26 , 2014 , in Pittsburgh , Pennsylvania , outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM . Analysis was conducted with an intent-to-treat population . INTERVENTIONS Participants were r and omized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments ( Roux-en-Y gastric bypass [ RYGB ] or laparoscopic adjustable gastric b and ing [ LAGB ] ) followed by low-level lifestyle intervention in years 2 and 3 . MAIN OUTCOMES AND MEASURES Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change . RESULTS Body mass index ( calculated as weight in kilograms divided by height in meters squared ) was less than 35 for 26 participants ( 43 % ) , 50 ( 82 % ) were women , and 13 ( 21 % ) were African American .  Mean ( SD ) values were 100.5 ( 13.7 ) kg for weight , 47.3 ( 6.6 ) years for age , 7.8 % ( 1.9 % ) for hemoglobin A1c level , and 171.3 ( 72.5 ) mg/dL for fasting plasma glucose level . Partial or complete T2DM remission was achieved by 40 % ( n = 8) of RYGB , 29 % ( n = 6 ) of LAGB , and no intensive lifestyle weight loss intervention participants ( P = .004 ) . The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group , with 65 % of RYGB , 33 % of LAGB , and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 ( P < .001 ) . Mean ( SE ) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0 % ( 2.0 % ) , followed by LAGB at 15.0 % ( 2.0 % ) and lifestyle treatment at 5.7 % ( 2.4 % ) ( P < .01 ) . CONCLUSIONS AND RELEVANCE Among obese participants with T2DM , bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention result ed in more disease remission than did lifestyle intervention alone . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01047735 INTRODUCTION Coronary disease in its various forms of presentation is associated with a reduction in the patients ' own perception of their quality of life ( QoL ) . QoL is an important measure of effectiveness of treatment ; however , the predictors of QoL after admission for acute coronary syndrome ( ACS ) are not completely clear . AIM To identify the clinical , demographic and psychosocial characteristics of patients admitted for ACS that were predictive of QoL in clinical follow-up . METHODS  Physical and mental QoL  were prospect ively evaluated in 278 patients admitted for ACS , using Short Form-36  v2 physical ( PCS ) and mental ( MCS ) component summary scales . Based on the median PCS ( 55 ) and MCS ( 56 ) scores , the population was divided into two groups . Depressive symptoms were assessed using the Beck Depression Inventory . RESULTS The patients with a better QoL perception were male , young , smokers and had more than 12 years ' education . A greater proportion of patients with PCS and MCS below the median score presented prior cardiovascular events and depressive symptoms . A worse physical QoL perception was more common in unmarried , hypertensive and diabetic patients . There was no association between clinical evolution or in-hospital complications and baseline QoL scores . Baseline PCS and MCS were 55 + /- 24 and 55 + /- 27 and at 16 months , 63 + /- 25 and 66 + /- 29 . Clinical follow-up was achieved in 181 patients . A worse mental QoL perception at follow-up was related to female gender , baseline MCS < 56 and depressive symptoms . A PCS below median score at follow-up was more frequent in women and in patients with prior cardiovascular events , hypertension , diabetes , dyslipidemia and a lower level of education . Patients with better physical QoL at follow-up were smokers , presented higher baseline PCS and MCS , and had fewer depressive symptoms . Percutaneous myocardial revascularization was associated with a better physical QoL. In a logistic regression model the independent predictors of PCS were : gender , baseline PCS , level of education and prior cardiovascular events . Gender and depressive symptoms were independent predictors of MCS . CONCLUSIONS In the study population , baseline clinical and psychosocial characteristics were the most important predictors of QoL after ACS . Depression was associated with worse mental QoL. In-hospital evolution and treatment did not appear to strongly affect patients ' follow-up perceptions of BACKGROUND AND AIMS The prevalence of type 2 diabetes ( T2DM ) is increasing . Several studies have suggested a beneficial effect of several major dairy nutrients on insulin production and sensitivity . Conversely , harmful effects have been suggested as well . This study aim ed to investigate the impact of the full-range of dairy products and its association with incidence T2DM in Dutch adults aged ≥55 years participating in the Rotterdam Study . METHODS AND RESULTS  Dairy intake was assessed with a vali date d FFQ , including total , skimmed , semi-skimmed , full-fat , fermented , and non-fermented dairy , and subclasses of these product groups . Verified prevalent and incident diabetes were documented . Cox proportional hazards regression and spline regression were used to analyse data , adjusting for age , sex , alcohol , smoking , education , physical activity , body mass index , intake of total energy , energy-adjusted meat , and energy-adjusted fish intake . Median total dairy intake was 398 g/day ( IQR 259 - 559 g/day ) . Through 9.5 ± 4.1 years of follow-up , 393 cases of incident T2DM were reported . Cox and spline regression did not point towards associations of total dairy consumption , dairy consumption based on fat content , non-fermented or fermented dairy consumption , or individual dairy product consumption with incident T2DM . The HR for total dairy intake and T2DM was 0.93 ( 95 % CI : 0.70 - 1.23 ) in the upper quartile ( P-for trend 0.76 ) . CONCLUSIONS This prospect i ve cohort study did not point towards an association between dairy consumption and T2DM This study aims to investigate the impact of a health belief model (HBM)-based educational intervention on knowledge , beliefs , self-reported practice s , gestational and postpartum weight in women with gestational diabetes mellitus ( GDM ) . Subjects and Methods : A cluster r and omized controlled trial was performed , with r and omization at the level of Primary Health Care centers in three Egyptian cities . Eligible women with GDM were enrolled at 24 weeks pregnancy . The intervention group ( n = 103 ) received health education intervention based on the HBM construct . Control subjects ( n = 98 ) received the  usual care . The outcomes measured were : women ’s knowledge , beliefs , self-reported practice s , gestational weight gain ( GWG ) , and postpartum weight retention . Patients were investigated at baseline , at end of pregnancy , and at 6 weeks postpartum . Results : After the intervention , percentages of women who had high knowledge and beliefs scores had significantly increased from less than 50 % to more than 70 % in the intervention group ( p < 0.001 ) . More women in the intervention group reported practicing exclusive breast feeding ( 85.4 % ) and screening for T2DM ( 43.7 % ) at 6 weeks postpartum compared to the control group ( 63.3 and 19.4 % respectively ) ( p < 0.001 ) . More women with excessive body mass index in the intervention group ( 65 % ) compared to the control group ( 11.6 % ) were meeting recommended GWG ( p < 0.001 ) , and postpartum weight ( 37.7 , and 20.3 % respectively ) ( p < 0.01 ) . Conclusion : This intervention significantly improved knowledge , beliefs , self-reported practice s , and gestational and postpartum weight in patients with GDM . Further research is needed for investigating the effectiveness of applying early , multi-phase , and longer intervention Objective Attention control ( AC ) conditions are used to balance nonspecific attention in r and omized trials of behavioral interventions . Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature . The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral r and omized trial was unnecessary and possibly detrimental . Methods Exploratory analyses were performed in a r and omized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease , compared with AC and usual care ( UC ) conditions . The patient-centered counseling intervention was design ed to activate participants to ask their physician for lipid-lowering medication and /or increase dose intensity , increase medication adherence , and reduce fat intake . The AC condition involved attention-matched telephone-delivered health education , and the UC condition consisted of an educational pamphlet . Results At 12-month follow-up , the mean low-density lipoprotein cholesterol changes were −11.1 and −6.8 mg/dL in the UC and AC conditions , respectively ( p = .17 ) . The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC : 17.5 % versus 30.5 % ( p = .03 ) . No significant difference in other outcomes was observed between AC and UC . Conclusions AC has significantly worse medication outcomes , and there is no indication of a therapeutic effect on other end points . Implication s for the use of AC in behavioral r and omized trials are discussed . Trial Registration clinical trials.gov Identifier : NCT00217919 Objective : To identify the effects of a 1-year exercise intervention on myocardial dysfunction in patients with type 2 diabetes mellitus ( T2DM ) . Design : R and omised controlled trial , the Diabetes Lifestyle Intervention Study . Setting : University hospital . Patients : 223 T2DM patients without occult coronary artery disease , aged 18–75 were r and omised to an  exercise training group ( n = 111 ) or a usual care group ( n = 112 ) . Complete follow-up data were available in 176 ( 88 exercise , 88 usual care ) . Interventions : Exercise training consisted of gym , followed by telephone-monitored home-based exercise training . Main outcome measures : Tissue Doppler-derived myocardial velocities , strain-rate and strain , body composition , glycated haemoglobin ( HbA1c ) , maximum oxygen consumption ( VO2max ) and physical activity . Results : Overall changes in myocardial function were not different between groups despite improvements in waist circumference , fat mass , blood glucose , HbA1c , insulin sensitivity , VO2max and 6-minute walk distance in the intervention group ( p<0.05 ) . The latter also spent significantly more time in vigorous activity ( p<0.05 ) . A post-hoc analysis revealed that intervention patients who spent more time in both moderate and vigorous activity showed a significant improvement in myocardial tissue velocity ( p<0.01 ) , HbA1c ( p = 0.03 ) and VO2max ( p = 0.03 ) compared to controls . Myocardial strain rate ( p = 0.03 ) and HbA1c improved in intervention patients with the greatest increase in moderate activity ( p = 0.03 ) . Conclusions : In patients with T2DM , current exercise recommendations led to an improvement in metabolic function , but failed to improve myocardial function in the overall group . Patients with greater increases in both moderate and vigorous activity showed improvements in myocardial function , glycaemic control and cardiorespiratory fitness . Trial registration number : ACTRN12607000060448 According to the Centers for Disease Control and Prevention , 1 in 3 children born in 2000 in the United States will become diabetic . The odds are higher for African American and Hispanic children as nearly 50 % of them will develop diabetes . R and om screening is not effective in identifying children at risk for type 2 diabetes mellitus ( T2DM )  ; therefore , there is a need to apply screening strategies that guide the development of appropriate primary prevention efforts . To assess the prevalence of risk factors for T2DM , 1066 fifth- grade children were screened using American Diabetes Association guidelines . Overall , 22.6 % were found at risk ; African American and Hispanic children were almost 8 times more likely to be at risk when compared to Caucasians ( odds ratio = 7.41 and 7.87 ) . Children who reported watching TV/playing video games 2 or more hours/day were 73 % more likely to be at risk . Children identified to be at risk were referred to their primary care provider and were invited to participate in a counseling session . The environmental risk factors for T2DM identified in this study are modifiable and should be targeted in preventive interventions at the school and community level to reduce overweight and consequently prevent T2DM in children , especially among minority children BACKGROUND Registries have shown that quality of care for acute coronary syndromes ( ACS ) often falls below the st and ards recommended in professional guidelines . Quality improvement ( QI ) is a strategy to improve st and ards of clinical care for patients , but the efficacy of QI for ACS has not been tested in r and omized trials . METHODS We undertook a prospect i ve , cluster-r and omized , multicenter , multinational study to evaluate the efficacy of a QI program for ACS . Participating centers collected data on consecutive admissions for non-ST-elevation ACS for 4 months before the QI intervention and 3 months after . Thirty-eight hospitals in France , Italy , Pol and , Spain , and the United Kingdom were r and omized to receive the QI program or not , 19 in each group . We measured 8 in-hospital quality indicators ( risk stratification , coronary angiography , anticoagulation , β-blockers , statins , angiotensin-converting enzyme inhibitors , and clopidogrel loading and maintenance ) before and after the intervention and compared composite changes between the QI and non-QI groups . RESULTS A total of 2604 patients were enrolled . The absolute overall change in use of quality indicators in the QI group was 8.5 % compared with 0.8 % in the non-QI group ( odds ratio for achieving a quality indicator in QI versus non-QI 1.66 , 95 % CI 1.43 - 1.94 ; P < .001 ) . The main changes were observed in the use of risk stratification and clopidogrel loading dose . CONCLUSIONS The QI strategy result ed in a significant improvement in the quality indicators measured . This type of QI intervention can lead to useful changes in health care practice for ACS in a wide range of setting Type 2 diabetes mellitus ( T2DM ) is associated with increased  bladder cancer  incidence in some , but not all , studies . Many studies had limited statistical power and few examined risk by insulin-use , duration of diabetes or cancer stage . We examined the association between T2DM and bladder cancer incidence in the Cancer Prevention Study II Nutrition Cohort , a large prospect i ve study with information on insulin-use and duration of diabetes . Diabetes and insulin-use were ascertained from a question naire at study enrollment in 1992 or 1993 and up date d in 1997 and every 2 years thereafter . During follow-up through 2007 , 1,852 cases of incident bladder cancer were identified among 172,791 participants .  Multivariable adjusted relative risks ( RRs ) and 95 % confidence intervals ( CIs ) were estimated using extended Cox regression modeling . There were no associations of T2DM with the risk of bladder cancer overall ( RR = 1.01 , 95 % CI : 0.87 - 1.17 ) , noninvasive disease ( RR = 0.93 , 95 % CI : 0.76 - 1.14 ) or invasive disease ( RR = 1.13 , 95 % CI : 0.91 - 1.40 ) . Compared to participants without T2DM , risk of invasive bladder cancer was higher among participants who had had T2DM for > 15 years ( RR = 1.63 , 95 % CI : 1.09 - 2.43 ) and among those using insulin ( RR = 1.64 , 95 % CI : 1.18 - 2.27 ) . These results do not support an association of T2DM with overall bladder cancer incidence , but do suggest positive associations of long-term T2DM and insulin-use or other factors correlated with severe diabetes , with invasive bladder cancer incidence Background Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) can dramatically ameliorate  type 2 diabetes mellitus ( T2DM ) in morbidly obese patients . However , there is little evidence supporting the effectiveness of LRYGB in low body mass index ( BMI ) patients . The study was design ed to evaluate the safety and results of LRYGB for achieving T2DM remission in patients with BMI in the range of 25–35 kg/m2 . Methods Twenty-two patients ( two men and 20 women ) with T2DM underwent LRYGB .  Data on patient demographics , BMI , co-morbidities , and details of diabetes mellitus , including disease duration , family history , medication use , and remission , were prospect ively collected and analyzed . Results The mean age was 47 years ( range , 28–63 years ) , mean BMI was 30.81 ( range , 25.00–34.80 kg/m2 ) , and mean duration of T2DM onset was 6.57 years ( range , 1–20 years ) . Sixteen ( 72.27 % ) patients had a family history of T2DM . There was no mortality , but two ( 9 % ) patients experienced complications : an early gastrojejunostomy hemorrhage and frequent loose stools that required revision surgery . At 12 months , 14 ( 63.6 % ) patients showed T2DM remission , six ( 27.3 % ) showed glycemic control , and two ( 9.1 % ) showed improvement . The group achieving remission had a higher BMI ( p = 0.001 ) , younger age ( p = 0.002 ) , and shorter duration of diabetes ( p = 0.001 ) . These three factors may be predictors of diabetes resolution at 12 months . Conclusion Early intervention in low- BMI patients yields better remission rates because age , BMI , and duration of T2DM predict glycemic outcomes Our purpose was to investigate the effects of low-volume , high-intensity interval training ( HIT ) on cardiometabolic risk and exercise capacity in women with type 2 diabetes mellitus ( T2DM ) . Sedentary overweight/obese T2DM women ( age=44.5±1.8 years ; BMI = 30.5±0.6 kg/m(2 ) ) were r and omly assigned to a tri-weekly running-based HIT program ( n=13 ) or non-exercise control follow-up ( CON ; n=10 ) . Glycemic control , lipid and blood pressure levels , endurance performance , and anthropometry were measured before and after the follow-up ( 16 weeks ) in both groups . Medication intake was also assessed throughout the follow-up . Improvements ( P<0.05 ) on fasting glucose ( 14.3±1.4 % ) , HbA1c ( 12.8±1.1 % ) , systolic blood pressure ( 3.7±0.5 mmHg ) , HDL-cholesterol ( 21.1±2.8 % ) , triglycerides ( 17.7±2.8 % ) , endurance performance ( 9.8±1.0 % ) , body weight ( 2.2±0.3 % ) , BMI ( 2.1±0.3 % ) , waist circumference ( 4.0±0.5 % ) and subcutaneous fat ( 18.6±1.4 % ) were found after HIT intervention . Patients of HIT group also showed reductions in daily dosage of antihyperglycemic and antihypertensive medication during follow-up . No changes were found in any variable of CON group . The HIT-induced improvements occurred with a weekly time commitment 56 - 25 % lower than the minimal recommended in current guidelines . These findings suggest that low-volume HIT may be a time-efficient intervention to treat T2DM women Optimal P2Y12 receptor blockade is critical to prevent ischaemic recurrence in patients undergoing percutaneous coronary intervention ( PCI ) . We aim ed to compare the level of platelet reactivity ( PR ) inhibition achieved by prasugrel and ticagrelor loading dose ( LD ) in diabetic acute coronary syndrome ( ACS ) patients undergoing PCI . We performed a single-center prospect i ve open-label r and omised trial . Patients with diabetes mellitus undergoing PCI for an ACS were r and omised to receive prasugrel 60 mg or ticagrelor 180 mg . The primary endpoint of the study was the level of platelet reactivity ( PR ) assessed between 6 and 18 hours post-LD using the VASP index . We r and omised 100 diabetic patients undergoing PCI for an ACS . No difference was observed in baseline characteristics between the two groups . In particular , the rate of patient receiving insulin therapy was identical ( 25 vs 28.6 % ; p = 0.7 ) . Ticagrelor achieved a significantly lower PR compared to prasugrel loading dose ( 17.3 ± 14.2 vs 27.7 ± 23.3 % ; p=0.009 ) . In addition the rate of high on-treatment platelet reactivity , defined by a VASP ≥50 % , tend to be lower in the ticagrelor group although the difference did not reach statistical significance ( 6 vs 16 % ; p=0.2 ) . The rate of low on treatment PR was identical ( 60 vs 54 % ; p=0.8 ) . The present study demonstrates that ticagrelor LD is superior to prasugrel LD to reduce PR in ACS patients with diabetes mellitus . Whether the higher potency of ticagrelor could translate into a clinical benefit should be investigated Background Acute coronary syndrome ( ACS ) is a major cause of death from a non-communicable disease . Secondary prevention is effective for reducing morbidity and mortality , but evidence -based targets are seldom reached and new interventional methods are needed . The present study is a feasibility study of a telephone-based secondary preventive programme in an unselected ACS cohort . Methods The NAILED ( Nurse-based Age-independent Intervention to Limit Evolution of Disease ) ACS trial is a prospect i ve r and omized controlled trial . All eligible patients admitted for ACS were r and omized to usual follow-up by a general practitioner or telephone follow-up by study nurses . The intervention was made by continuous telephone contact , with counseling on healthy living and titration of medicines to reach target values for blood pressure and blood lipids . Exclusion criteria were limited to physical inability to follow the study design or participation in another study . Results A total of 907 patients were assessed for inclusion . Of these , 661 ( 72.9 % ) were included and r and omized , 100 ( 11 % ) declined participation , and 146 ( 16.1 % ) were excluded . The main reasons for exclusion were participation in another trial , dementia , and advanced disease .  “ Excluded ” and “ declining ” patients were significantly older with more co-morbidity , decreased functional status , and had more seldom received education above compulsory school level than “ included ” patients . Non- participants had a higher 1-year mortality than participants . Conclusions Nurse-led telephone-based follow-up after ACS can be applied to a large proportion in an unselected clinical setting . Reasons for non-participation , which were associated with increased mortality , include older age , multiple co-morbidities , decreased functional status and low level of education . Trial registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : IS RCT N96595458 ( archived by WebCite at http://www.webcitation.org/6RlyhYTYK ) . Application date : 10 July 2011 BACKGROUND There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease . There are no studies from low- to middle income countries ( LMICs ) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease . METHODS We design ed a hospital-based , open r and omized trial of CHW-based interventions versus st and ard care .  Patients after an acute coronary syndrome ( ACS ) were r and omized to an intervention group ( a CHW-based intervention package , comprising education tools to enhance self-care and adherence , and regular follow-up by the CHW ) or to st and ard care for 12 months during which study outcomes were recorded . The CHWs were trained over a period of 6 months . The primary outcome measure was medication adherence . The secondary outcomes were differences in adherence to lifestyle modification , physiological parameters ( blood pressure [ BP ] , body weight , body mass index [ BMI ] , heart rate , lipids ) , and major adverse cardiovascular events . RESULTS We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities . The mean age was 56.4 ( ± 11.32 ) years , and 17.2 % were females . A high prevalence of risk factors such as hypertension ( 43.4 % ) , diabetes ( 31.9 % ) , tobacco consumption ( 35.4 % ) , and inadequate physical activity ( 70.5 % ) was documented . A little over half had ST-elevation myocardial infa rct ion ( 53.7 % ) , and 46.3 % had non-ST-elevation myocardial infa rct ion or unstable angina . CONCLUSION The CHW interventions and training for SPREAD have been developed and adapted for local use . The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries The profound effects of bariatric surgery on glycemic control are well established in many studies , including several r and omized trials that compared surgery versus intensive medical and lifestyle treatment of type 2 diabetes mellitus ( T2DM ) ( 17 ) . Remission of T2DM is common after bariatric surgery , and Roux-en-Y gastric bypass ( RYGB ) outperforms sleeve gastrectomy ( SG ) in most reports ( 4 , 8 , 9 ) . More important than improvements in glycemic control is whether these glycemic changes reduce the incidence of major complications , such as microvascular events . In the United States , T2DM is the primary cause of nephropathy , end-stage renal disease , adult blindness , and neuropathy , which together lead to significant downstream costs and decreased quality of life ( 1012 ) . Thus , a major goal of diabetes treatment is to mitigate the risk for these long-term sequelae ( 13 ) . We have previously shown that in patients with T2DM who have bariatric surgery  , risk for incident microvascular disease is reduced for every year of remission from T2DMeven if patients eventually relapse back to T2DM ( indicating a legacy effect ) ( 14 ) . However , a detailed 2016 review of long-term microvascular outcomes of diabetes concluded that data were inadequate to support a superior effect of bariatric surgery compared with medical therapy ( 15 ) . Two recently published studies help inform this question ( 4 , 16 ) . The STAMPEDE ( Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently ) trial ( 4 ) r and omly assigned 150 patients with obesity and T2DM to have RYGB , SG , or an intensive medical and lifestyle intervention . After 5 years , urinary albumincreatinine ratios had decreased in the SG group only . Retinopathy did not change in any group , and neuropathy was not examined . STAMPEDE was limited by a relatively small sample size , which made it underpowered for rare outcomes . The prospect i ve SOS ( Swedish Obesity Subjects ) matched cohort study ( 16 ) followed 2010 patients who had bariatric surgery ( 13 % RYGB , 19 % gastric b and ing , and 68 % vertical-b and ed gastroplasty ) and 2037 matched patients who received usual care .  The incidence of microvascular disease after 15 years of follow-up was significantly lower in the surgery group than the control group ( hazard ratio [ HR ] , 0.56 [ 95 % CI , 0.48 to 0.66 ] ) , including among subgroups with prediabetes ( HR , 0.18 [ CI , 0.11 to 0.30 ] ) , established diabetes ( HR , 0.54 [ CI , 0.40 to 0.72 ] ) , and normoglycemia ( HR , 0.63 [ CI , 0.48 to 0.81 ] ) at baseline . The SOS study was limited by the small number of RYGB procedures and lack of SG procedures , which are now the 2 most common bariatric procedures worldwide ( 17 ) . To address these gaps in the literature , we did a matched cohort study to determine whether bariatric surgery was associated with lower incidence of microvascular disease than usual care for severe obesity and T2DM . We hypothesized that patients having  bariatric surgery would have lower risk for any incident microvascular disease ( composite of the first occurrence of retinopathy , neuropathy , or nephropathy ) . We further hypothesized that patients having bariatric surgery would have lower risk for incident retinopathy , nephropathy , and neuropathy than nonsurgical patients . Methods Setting s We did a retrospective observational cohort study of adults with T2DM who had bariatric surgery between 2005 and 2011 while enrolled in 1 of 4 integrated health care systems from the Health Care Systems Research Network : Kaiser Permanente ( KP ) Washington in Washington state , HealthPartners in Minnesota , KP Northern California , and KP Southern California . All study procedures were review ed and approved by the institutional review board at each site , and we were permitted to do the research without explicit consent from participants . Data Sources At each study site , staff used st and ardized electronic medical records , insurance cl aims , and other data systems ( 18 ) to extract enrollee data , including enrollment and insurance coverage ; demographics ; blood pressure ; height ; weight ; laboratory values ; medications dispensed ; deaths ; outpatient , inpatient , and emergency department use ; and inpatient and outpatient diagnosis and procedure codes . Surgical Participants The bariatric population included adults ( aged 19 to 79 years ) with severe obesity ( body mass index [ BMI ] 35 kg/m2 ) and T2DM who had a primary ( first observed ) bariatric surgical procedure between 1 January 2005 and 31 December 2011 . Following an approach adopted in prior studies ( 14 , 19 , 20 ) , we used a combination of bariatric registries ; review of medical records ; codes from the International Classification of Diseases , Ninth Revision ( ICD-9 ) ( 43.89 , 44.31 , 44.38 , 44.39 , 44.68 , 44.69 , and 44.95 ) ; and Current Procedural Terminology codes ( 43633 , 43644 , 43645 , 43659 , 43770 , 43775 , 43842 , 43843 , 43844 , 43845 , 43846 , and 43847 ) to identify bariatric procedures .  Patients were classified as having T2DM if they had a hemoglobin A1c ( HbA1c ) level of at least 6.5 % or fasting plasma glucose level of at least 6.99 mmol/L ( 126 mg/dL ) at the most recent measurement within 2 years before surgery , or a current prescription for any diabetes medication . After selecting the population , we applied the following exclusion criteria based on information in the 2 years before surgery : less than 1 full year of continuous enrollment ; history of gastrointestinal surgery for cancer ; pregnancy in the year before surgery ; gestational diabetes as the sole diabetes diagnosis ; metformin as the sole indicator of possible T2DM ( that is , no other T2DM medications , laboratory values , or diagnoses ) ; preexisting neuropathy , retinopathy , or nephropathy ( defined in Outcome and Censoring Definitions ) ; and maximum preoperative BMI less than 35 kg/m2 . This left 4972 patients . We further excluded 850 patients who were missing values for BMI , HbA1c level , or serum creatinine concentration in the 2 years before surgery . Surgical patients who were missing these values differed from those who had complete data ( Appendix Table 1 ) . Specifically , they were more likely to be non-Hispanic white , to be from the HealthPartners site , to have had their procedure in the first year of our study ( 2005 ) , and to have had a shorter observed duration of T2DM at the time of surgery . Of the remaining 4122 patients , 4024 could be matched to at least 1 nonsurgical patient ( Figure 1 ) . Figure 1 . Flow diagram for identification of eligible patients with T2DM and no history of microvascular disease who had bariatric surgery .  BMI = body mass index ; EHR= electronic health record ; HbA1c= hemoglobin A1c ; T2DM= type 2 diabetes mellitus . * Adults aged 2079 y who had a primary ( first observed ) bariatric surgical procedure between 1 January 2005 and 31 December 2011 .  Bariatric procedures were identified using a combination of bariatric registries ; review of medical records ; International Classification of Diseases , Ninth Revision , codes ( 43.89 , 44.31 , 44.38 , 44.39 , 44.68 , 44.69 , and 44.95 ) ; and Current Procedural Terminology codes ( 43633 , 43644 , 43645 , 43659 , 43770 , 43775 , 43842 , 43843 , 43844 , 43845 , 43846 , and 43847 ) . We excluded patients with any of the following : < 1 y of continuous enrollment ; history of gastrointestinal surgery for cancer ; pregnancy in the year before surgery ; gestational diabetes as the sole diabetes diagnosis ; preexisting neuropathy , nephropathy , or retinopathy ; metformin as the sole indicator of possible T2DM ( no other T2DM medications , laboratory values , or diagnoses ) ; or maximum BMI < 35 kg/m2 . Patients may have > 1 type of missing data ( BMI , creatinine concentration , or HbA1c level ) or have no follow-up time after surgery . 98 surgical patients could not be matched to a nonsurgical patient on site , age , BMI , insulin use , HbA1c level , and sex . Appendix Table 1 . Comparison of Characteristics of Surgical Patients Who Were Missing Values for BMI , HbA1c , or Serum Creatinine at Baseline Versus Those Who Had Complete Information on These Values at Baseline Matched Nonsurgical Participants For each surgical patient , we identified up to 3 matched nonsurgical control participants via a 2-step process . First , among all patients with diabetes and at least 1 BMI measurement of 35 kg/m2 or greater who did not have bariatric surgery during the study ( n= 320345 ) , we identified a pool of potential control participants who were enrolled at the time of the surgery ; satisfied the study inclusion criteria ; and matched the surgical patient on the basis of study site , sex , age ( 10 years ) , BMI ( 5 kg/m2 ) , HbA1c level ( 1.5 percentage points ) , and insulin use . Second , for each control participant in the pool , we calculated Mahalanobis distance from the surgical patient on the basis of age , BMI , HbA1c level , diabetes duration , and total days of health care use in the 7 to 24 months before the date of surgery ( 21 ) . Finally , up to 3 control participants were selected on the basis of the shortest Mahalanobis distance . Throughout , nonsurgical patients could be used as a control for only 1 surgical patient ( matching without replacement ) . The Appendix gives additional details on the process we used to establish the matched cohort . Outcome and Censoring Definitions The primary outcome measure was time to incident microvascular disease ( composite of the first occurrence of retinopathy , neuropathy , or nephropathy ) . Retinopathy was defined by the first appearance of either ICD-9 code 362.0x ( diabetic retinopathy ) or both a retinal surgical procedure code or other retinopathic code ( Appendix Table 2 ) and ICD-9 code 250.5x ( diabetes with ophthalmic manifestations ) . Neuropathy was identified on the basis of the first occurrence of ICD-9 code 250.6 ( diabetes with neurologic manifestations ) or 357.2 ( polyneuropathy in diabetes ) . Finally , nephropathy was defined by at least 2 measures of estimated glomerular filtration rate less than 60 mL/min/1.73 m2 separated by at least 90 days without any intervening values of 60 mL/min/1.73 m2 or greater . We approximated AIMS Type 2 diabetes mellitus ( T2DM ) can substantially decrease quality of life ( QOL ) . This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM . METHODS A year-long multi-site r and omized clinical trial compared the Weight Watchers ( WW ) approach , supplemented with phone and email counseling with a certified diabetes educator ( CDE ) , to brief st and ard diabetes nutrition counseling and education ( St and ard Care ; SC ) . Participants were 400 women and 163 men ( N=279 WW ; 284 SC ) with T2DM [ mean ( ±SD ) HbA1c 8.32±1 % ; BMI = 37.1±5.7kg/m2 ; age=55.1 ± 9.1years ] . Psychosocial outcomes were assessed at baseline , month 6 , and month 12 using a diabetes specific psychosocial measure ( Diabetes Distress Scale [ DDS ] ) , Impact of Weight on Quality of Life-Lite scale ( IWQOL ) , a generic QOL measure ( SF-36 ) , and a depression screen ( PHQ-9 ) . RESULTS WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function , sex life and work domains ( all ps<.05 ) . There was no significant treatment effect on SF-36 scores or PHQ-9 . CONCLUSIONS WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity . Available commercial WL programs , combined with scalable complementary program-specific diabetes counseling , may have benefits that extend to diabetes-related distress and weight-relevant QOL CONTEXT Polycystic ovary syndrome ( PCOS ) affects 6%-21 % of women . PCOS has been associated with an increased risk of dysglycemia including gestational diabetes mellitus ( GDM ) and type 2 diabetes mellitus ( T2DM ) . OBJECTIVE The objective of the study was to assess the prevalence of dysglycemia and the impact of obesity in young reproductive-aged women with and without PCOS in a community-based cohort . DESIGN This was a cross-sectional analysis of data from a large longitudinal study ( the Australian Longitudinal Study on Women 's Health ) . SETTING The setting for the study was the general community . PARTICIPANTS Women were r and omly selected from the national health insurance data base . St and ardized data collection occurred at five survey time points ( years 1996 , 2000 , 2003 , 2006 , and 2009 ) . Data from survey 4 ( 2006 , n = 9145 , 62 % of original cohort aged 18 - 23 y ) were examined for this study . MAIN OUTCOME MEASURES Self-reported PCOS , GDM , and T2DM were measured . RESULTS In women aged 28 - 33 years , PCOS prevalence was 5.8 % [ 95 % confidence interval ( CI ) 5.3%-6.4 % ] . The prevalence of GDM ( in women reporting prior pregnancy ) and T2DM was 11.2 % and 5.1 % in women with PCOS and 3.8 % and 0.3 % in women without PCOS , respectively ( P for both < .001 ) . PCOS was associated with an increased odds of GDM and T2DM . After adjusting for age , body mass index , hypertension , smoking , and demographic factors , the odds of GDM ( odds ratio 2.1 , 95 % CI 1.1 - 3.9 , P = .02 ) and T2DM ( odds ratio 8.8 , 95 % CI 3.9 - 20.1 , P < .001 ) remained increased in women reporting PCOS . CONCLUSIONS In a large community-based cohort of reproductive-aged women , PCOS was independently associated with a higher risk of GDM and T2DM , independent of body mass index . Aggressive screening , prevention , and management of dysglycemia is clearly warranted in women with PCOS Purpose The purpose of the study was to investigate the effects of a family-based self-management support intervention for adults with type 2 diabetes ( T2DM ) . Methods Using a 2-group , experimental repeated measures design , 157 dyads ( participant with T2DM and family member ) were r and omly assigned to an intervention ( education , social support , home visits , and telephone calls ) or a wait list control group . Data were collected at baseline , postintervention ( 3 months ) , and 6 months postintervention . A series of 2 × 3 repeated measures ANOVAs were used to test the hypotheses with interaction contrasts to assess immediate and sustained intervention effects . Results Significant changes over time were reported in diet self-management , exercise self-management , total self-management , diabetes self-efficacy for general health and total diabetes self-efficacy , physician distress , regimen distress , interpersonal distress , and total distress . There were likewise sustained effects for diet self-management , total self-management , diabetes self-efficacy for general health , total self-efficacy , physician distress , regimen distress , and interpersonal distress . Conclusions Results support and extend prior research documenting the value of culturally relevant family-based interventions to improve diabetes self-management and substantiate the need for intensive , longer , tailored interventions to achieve glycemic control Background The prevention of type 2 diabetes is a globally recognised health care priority , but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes , based on the promotion of a healthy lifestyle , into routine primary care . The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation ( a composite of impaired glucose tolerance and /or impaired fasting glucose ) identified through a vali date d risk score screening programme in primary care . Design Cluster r and omised controlled trial undertaken at the level of primary care practice s. Follow-up will be conducted at 12 , 24 and 36 months . The primary outcome is the incidence of type 2 diabetes . Secondary outcomes include changes in HbA1c , blood glucose levels , cardiovascular risk , the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention . Methods The study consists of screening and intervention phases within 44 general practice s coordinated from a single academic research centre . Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test . Those with screen detected impaired glucose regulation will be invited to take part in the trial . Practice s will be r and omised to st and ard care or the intensive arm . Participants from intensive arm practice s will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions . The study will run from 2009–2014 . Discussion This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom . Trial registration Clinical trials.gov AIM To determine whether glycemic control is improved when motivational interviewing ( MI ) , a patient-centered behavior change strategy , is used with diabetes self management education ( DSME ) as compared to DSME alone . METHODS poorly controlled type 2 diabetes ( T2DM ) patients ( n=234 ) were r and omized into 4 groups : MI+DSME or DSME alone , with or without use of a computerized summary of patient self management barriers . We compared HbA1c changes between groups at 6 months and investigated mediators of HbA1c change . RESULTS study patients attended the majority of the four intervention visits ( mean 3.4 ) , but drop-out rate was high at follow-up research visits ( 35 % ) . Multiple regression showed that groups receiving MI had a mean change in HbA1c that was significantly lower ( less improved ) than those not receiving MI ( t=2.10 ; p=0.037 ) . Mediators of HbA1c change for the total group were diabetes self-care behaviors and diabetes distress ; no between-group differences were found . CONCLUSIONS DSME improved blood glucose control , underlining its benefit for T2DM management . However , MI+DSME was less effective than DSME alone . Overall , weak support was found for the clinical utility of MI in the management of T2DM delivered by diabetes educators UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT Abstract Objective : This study constructed the Economic and Health Outcomes  Model for type 2 diabetes mellitus ( ECHO-T2DM )  , a long-term stochastic microsimulation model , to predict the costs and health outcomes in patients with T2DM . Naturally , the usefulness of the model depends upon its predictive accuracy . The objective of this work is to present results of a formal validation exercise of ECHO-T2DM . Methods : The validity of ECHO-T2DM was assessed using criteria recommended by the International Society for Pharmacoeconomics and Outcomes Research /Society for Medical Decision Making ( ISPOR/SMDM ) . Specifically , the results of a number of clinical trials were predicted and compared with observed study end-points using a scatterplot and regression approach . An F-test of the best-fitting regression was added to assess whether it differs statistically from the identity ( 45 ° ) line defining perfect predictions . In addition to testing the full model using all of the validation study data , tests were also performed of microvascular , macrovascular , and survival outcomes separately . The validation tests were also performed separately by type of data ( used vs not used to construct the model , economic simulations , and treatment effects ) . Results : The intercept and slope coefficients of the best-fitting regression line between the predicted outcomes and corresponding trial end-points in the main analysis were −0.0011 and 1.067 , respectively , and the R2 was 0.95 . A formal F-test of no difference between the fitted line and the identity line could not be rejected ( p = 0.16 ) . The high R2 confirms that the data points are closely ( and linearly ) associated with the fitted regression line . Additional analyses identified that disagreement was highest for macrovascular end-points , for which the intercept and slope coefficients were 0.0095 and 1.225 , respectively . The R2 was 0.95 and the estimated intercept and slope coefficients were 0.017 and 1.048 , respectively , for mortality , and the F-test was narrowly rejected ( p = 0.04 ) . The sub-set of microvascular end-points showed some tendency to over-predict ( the slope coefficient was 1.095 ) , although concordance between predictions and observed values could not be rejected ( p = 0.16 ) . Limitations : Important study limitations include : ( 1 ) data availability limited one to tests based on end-of- study outcomes rather than time-varying outcomes during the studies analyzed ; ( 2 ) complex inclusion and exclusion criteria in two studies were difficult to replicate ; ( 3 ) some of the studies were older and reflect out date d treatment patterns ; and ( 4 ) the authors were unable to identify published data on re source use and costs of T2DM suitable for testing the validity of the economic calculations . Conclusions : Using conventional methods , ECHO-T2DM simulated the treatment , progression , and patient outcomes observed in important clinical trials with an accuracy consistent with other well-accepted models . Macrovascular outcomes were over-predicted , which is common in health-economic models of diabetes ( and may be related to a general over-prediction of event rates in the United Kingdom Prospect i ve Diabetes Study [ UKPDS ] Outcomes Model ) . Work is underway in ECHO-T2DM to incorporate new risk equations to improve model prediction Introduction Delay to presentation with symptoms of acute coronary syndrome ( ACS ) is common meaning many fail to achieve optimal benefit from treatments . Interventions have had variable success in reducing delay . Evidence suggests inclusion of behaviour change techniques ( BCTs ) may improve effectiveness of interventions but this has not yet been systematic ally evaluated . Data from other time-critical conditions may be relevant . Methods and analysis A systematic review will be undertaken to identify which BCTs are associated with effective interventions to reduce patient delay ( or prompt rapid help-seeking ) among people with time-critical conditions ( eg , chest pain , ACS , lumps , stroke , cancer and meningitis ) . A systematic search of a wide range of data bases ( including Cochrane Library , MEDLINE , EMBASE , CINAHL , PsycInfo ) and grey literature will be undertaken to identify all relevant intervention studies ( r and omised controlled trials , controlled clinical trials and cohort studies ) . Two independent review ers will screen abstract s to identify relevant studies , apply inclusion criteria to full papers , assess method ological quality and extract data . Primary outcome measure Change in patient decision time BCTs reported in each of the included studies will be categorised and presented according to the latest reliable taxonomy . Results of included studies will be synthesis ed , exploring relationships between inclusion of each BCT and effectiveness of the overall intervention . Where possible , means and SDs for differences in delay time will be calculated and combined within meta-analyses to derive a st and ardised mean difference and 95 % CI . Analysis of ( 1 ) all time-critical and ( 2 ) ACS-only interventions will be undertaken . Ethics and dissemination No ethical issues are anticipated . Results will be su bmi tted for publication in a relevant peer- review ed journal Type 2 diabetes mellitus ( T2DM ) is associated with  dementia .  Mild cognitive impairment ( MCI ) is a key determinant in this association . It is not clear whether T2DM increases the risk of conversion from MCI to dementia . We plan to explore the relationship between T2DM-MCI and dementia and identify its potential risk factors . A prospect i ve community-based cohort study was conducted from March 2010 to March 2014 , including 634 participants with T2DM-MCI , 261 T2DM participants who were cognitively intact , and 585 MCI participants without diabetes . All cohort members received detailed annual evaluations to detect dementia onset during the 5 years of follow-up . The three cohorts were compared to assess differences in dementia onset . Furthermore , Cox proportional hazards regression was used to identify risk factors for dementia onset in the T2DM-MCI cohort . During follow-up , 152 and 49 subjects developed dementia in the MCI and cognitively-intact cohorts , amounting to an adjusted hazard ratio ( HR ) of 1.66 ( 95 % CI 1.07 - 2.26 ) . In a survival analysis of the cohorts ,  MCI  accelerated the median progression to dementia by 2.74 years . In a multivariable analysis of the T2DM-MCI cohort , major risk factors for dementia were age > 75 years and longer duration s of diabetes , while significantly reduced risks of dementia were associated with oral hypoglycemic agents and HMG-CoA reductase inhibitors . Insulin was not associated with significantly changed risk . T2DM-MCI may aggravate the clinical picture as a concomitant factor . To minimize progression to dementia , it may be worthwhile to target several modifiable diabetes-specific features , such as the duration of disease , glycemic control , and antidiabetic agents Objectives : This umbrella review aim ed to determine the effectiveness of exercise interventions , alone or in combination with other interventions , in improving physical function in community-dwelling older people identified as pre-frail or frail . Introduction : Exercise is said to have a positive impact on muscle mass and strength which improves physical function and hence is beneficial for the treatment of frailty . Several systematic review s discuss the effects of exercise interventions on physical function parameters , such as strength , mobility , gait , balance and physical performance , and indicate that multi-component exercise , including resistance , aerobic , balance and flexibility training , appears to be the best way in which to improve physical function parameters in frail older people . However , there is still uncertainty as to which exercise characteristics ( type , frequency , intensity , duration and combinations ) are the most effective and sustainable over the long-term . Inclusion criteria : Participants were adults , 60 years or over , living in the community and identified as pre-frail or frail . Quantitative systematic review s , with or without meta- analysis that examined the effectiveness of exercise interventions of any form , duration , frequency and intensity , alone or in combination with other interventions design ed to alter physical function parameters in frail older people , were considered . The quantitative outcome measures were physical function , including muscular strength , gait , balance , mobility and physical performance . Methods : An iterative search strategy for ten bibliometric data bases and gray literature was developed . Critical appraisal of seven systematic review s was conducted independently by two review ers using a st and ard Joanna Briggs Institute tool . Data was extracted independently by two review ers using a st and ard Joanna Briggs Institute data extraction tool and summarized using a narrative synthesis approach . Results : Seven systematic review s were included in this umbrella review , with a total of 58 relevant r and omized controlled trials and 6927 participants . Five systematic review s examined the effects of exercise only , while two systematic review s reported on exercise in combination with a nutritional approach , including protein supplementations , as well as fruit and dairy products . The average  exercise frequency was 2–3 times per week ( mean 3.0 ± 1.5 times per week ; range 1–7 weekly ) for 10–90 minutes per session ( mean of 52.0 ± 16.5 mins ) and a total duration of 5–72 weeks with the majority lasting a minimum of 2.5 months ( mean 22.7 ± 17.7 weeks ) . Multi-component exercise interventions can currently be recommended for pre-frail and frail older adults to improve muscular strength , gait speed , balance and physical performance , including resistance , aerobic , balance and flexibility tasks . Resistance training alone also appeared to be beneficial , in particular for improving muscular strength , gait speed and physical performance . Other types of exercise were not sufficiently studied and their effectiveness is yet to be established . Conclusions : Interventions for pre-frail and frail older adults should include multi-component exercises , including in particular resistance training , as well as aerobic , balance and flexibility tasks . Future research should adopt a consistent definition of frailty and investigate the effects of other types of exercise alone or in combination with nutritional interventions so that more specific recommendations can be made Background Current guidelines consider diabetes per se as a coronary artery disease ( CAD ) risk equivalent . We aim ed at investigating the contribution of baseline coronary atherosclerosis to the risk of diabetic patients for future vascular events . Design Prospect i ve cohort study . Methods Vascular events were recorded over 4 years in 750 consecutive patients undergoing coronary angiography for the evaluation of stable CAD . Results From our patients , 244 had neither type 2 diabetes ( T2DM ) nor significant CAD ( i.e. coronary stenoses ≥ 50 % ) at the baseline angiography , 50 had T2DM but not significant CAD , 342 did not have T2DM but had significant CAD , and 114 had both T2DM and significant CAD . Nondiabetic patients without significant CAD had an event rate of 9.0 % . The event rate was similar in T2DM patients without significant CAD ( 8.0 % , P = 0.951 ) , but higher in nondiabetic patients with significant CAD ( 24.9 % , P < 0.001 ) . Patients with T2DM and significant CAD had the highest event rate ( 43.0 % ) . Importantly , T2DM patients without significant CAD had a significantly lower event rate than nondiabetic patients with significant CAD ( P = 0.008 ) . Conclusion T2DM per se is not a CAD risk equivalent . Moderate-risk diabetic patients without significant CAD and very high-risk diabetic patients with significant CAD add up to a gr and total of high-risk diabetic patients , this is why diabetes seems to be a CAD risk equivalent in many epidemiological studies BACKGROUND  Erectile dysfunction ( ED ) is a frequent comorbidity in patients with type 2 diabetes mellitus ( T2DM ) , and is now increasingly considered a surrogate marker of endothelial dysfunction as well as a sentinel predictor of new-onset macroangiopathic events . Less attention , however , has been directed at the potential association of ED and microangiopathy in hyperglycaemic states . METHODS We analyzed 221 consecutive male T2DM out patients in whom ED was assessed by the International Index of Erectile Function ( IIEF-5 ) question naire . ED(+ ) patients ( IIEF-5 1 - 20 ; n=83 ) were compared with an age-matched ED(- ) cohort ( IIEF-5 21 - 25 ; n=51 ) , with similar diabetes duration , in terms of cardiovascular ( CV ) risk factors , micro-/macroangiopathy and the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) risk score . RESULTS Mean age and diabetes duration were 58 and 10 years , respectively . IIEF-5 score ( 1 S.D ) was 23 ( 1 ) in ED(- ) vs 11 ( 6 ) in ED(+ ) . Anamnestic impotence and erectogenic drug use were reported by 52 % and 36 % , respectively , of ED(+ ) vs 12 % and 8 % , respectively , of ED(- ) ( P<0.0002 and P<0.0001 , respectively ) . The metabolic syndrome prevalence ( 88 % vs 64 % ; P=0.002 ) and central adiposity markers ( waist , waist/height and visceral fat ) were all significantly higher in ED(+ ) . HbA(1c ) was similar in both groups : 7.5 % ( 1.3 % ) , and there were also no significant differences in smoking , blood pressure , HOMA insulin sensitivity , cholesterol and glomerular filtration rate . However , prevalences of retinopathy , polyneuropathy and elevated albuminuria , and the composite endpoint of peripheral artery disease , transient ischaemic attacks and /or stroke , were markedly increased in ED(+ ) ( all P<0.05 ) . No differences were observed in coronary artery disease prevalence or in the UKPDS 10-year CV risk between the two ED groups . CONCLUSION IIEF-5-defined ED in men with T2DM is associated with a marked increase in the metabolic syndrome , central adiposity and microangiopathy . These data suggest that diagnosing ED in T2DM warrants detailed screening and monitoring for microangiopathy in target organs Background — After treatment with clopidogrel , patients with type 2 diabetes mellitus ( T2DM ) have reduced platelet inhibition compared with patients who are not diabetic . Whether platelet inhibition can be enhanced by increasing clopidogrel maintenance dosage in T2DM patients is unknown . The aim of this pilot study was to assess the functional impact of a high maintenance dose in T2DM patients with suboptimal clopidogrel-induced antiplatelet effects . Methods and Results — T2DM patients on chronic dual antiplatelet therapy were screened to identify suboptimal clopidogrel responders . The latter were r and omized to 30-day treatment with a st and ard ( 75 mg ; n=20 ) or high ( 150 mg ; n=20 ) daily maintenance dose . Platelet function was assessed at 3 time points : baseline , 30 days after r and omization , and 30 days after resuming st and ard dosing . Platelet function parameters included adenosine diphosphate – induced ( 20 and 5 & mgr;mol/L ) maximal and late platelet aggregation , inhibition of platelet aggregation , platelet disaggregation , and P2Y12 reactivity index . A total of 64 T2DM patients were screened to identify 40 suboptimal responders . After r and omization , maximal adenosine diphosphate – induced ( 20 & mgr;mol/L ) platelet aggregation was significantly reduced in the 150-mg group compared with the 75-mg group ( P=0.002 ; primary end point ) . However , suboptimal clopidogrel response was still present in 60 % of patients on the 150-mg regimen . All other platelet function parameters showed enhanced clopidogrel-induced antiplatelet effects with 150 mg , which returned to baseline values after resumption of st and ard dosing . Conclusions — A 150-mg maintenance dose of clopidogrel is associated with enhanced antiplatelet effects compared with 75 mg in high-risk T2DM patients . However , enhanced ex vivo platelet reactivity continues to persist , the clinical implication s of which are unknown and need to be evaluated in large-scale clinical trials Objective Genome-wide association studies ( GWASs ) identified that SLC30A8 genetic polymorphism was a risk of type 2 diabetes mellitus ( T2DM ) in several population s. This study aim ed to investigate whether the SLC30A8 rs13266634 and rs16889462 polymorphisms were associated with T2DM susceptibility and repaglinide therapeutic efficacy in Chinese T2DM patients . Methods We conducted a case – control study of 443 T2DM patients and 229 healthy volunteers to identify SLC30A8 rs13266634 and rs16889462 genotypes by polymerase chain reaction – restriction fragment length polymorphism ( PCR-RFLP ) assay . Forty-eight patients were r and omly selected and underwent an 8-week repaglinide treatment ( 3 mg/d ) . Fasting plasma glucose ( FPG ) , postpr and ial plasma glucose ( PPG ) , glycated hemoglobin ( HbAlc ) , fasting serum insulin ( FINS ) , postpr and ial serum insulin ( PINS ) , homeostasis model assessment for insulin resistance ( HOMA-IR ) , serum triglyceride , total cholesterol ( TC ) , low-density lipoprotein-cholesterol ( LDL-c ) and high-density lipoprotein-cholesterol ( HDL-c ) were determined before and after repaglinide treatment . Results SLC30A8 rs13266634 risk C allele frequency was higher in T2DM patients than in healthy controls ( P < 0.05 ) . There was a better repaglinide response on FINS ( P < 0.05 ) and PINS ( P < 0.01 ) in patients with rs13266634 CT+TT genotypes compared with CC genotype carriers . Patients with rs16889462 GA genotype showed an enhanced repaglinide efficacy on FPG ( P < 0.01 ) , PPG ( P < 0.01 ) and HbAlc ( P < 0.05 ) compared with GG genotype individuals . Conclusions SLC30A8 rs13266634 and rs16889462 polymorphisms were associated with repaglinide therapeutic efficacy in Chinese T2DM patients Objectives Dual antiplatelet therapy ( DAPT ) with aspirin + a P2Y12 inhibitor is recommended for at least 12 months for patients with acute coronary syndrome ( ACS ) , with shorter duration s considered for patients with increased bleeding risk . However , there are no decision support tools available to predict an individual patient ’s bleeding risk during DAPT treatment in the post-ACS setting . Methods To develop a longitudinal bleeding risk prediction model , we analy sed 9240 patients with unstable angina/non-ST segment elevation myocardial infa rct ion ( NSTEMI ) from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes ( TRILOGY ACS ) trial , who were managed without revasculari sation and treated with DAPT for a median of 14.8 months . Results We identified 10 significant baseline predictors of non-coronary artery bypass grafting (CABG)-related Global Use of Strategies to Open Occluded Arteries ( GUSTO ) severe/life-threatening/moderate bleeding : age , sex , weight , NSTEMI ( vs unstable angina ) , angiography performed before r and omi sation , prior peptic ulcer disease , creatinine , systolic blood pressure , haemoglobin and treatment with beta-blocker . The five significant baseline predictors of Thrombolysis In Myocardial Infa rct ion ( TIMI ) major or minor bleeding included age , sex , angiography performed before r and omi sation , creatinine and haemoglobin . The models showed good predictive accuracy with Therneau ’s C-indices : 0.78 ( SE = 0.024 ) for the GUSTO model and 0.67 ( SE = 0.023 ) for the TIMI model . Internal validation with bootstrapping gave similar C-indices of 0.77 and 0.65 , respectively . External validation demonstrated an attenuated C-index for the GUSTO model ( 0.69 ) but not the TIMI model ( 0.68 ) . Conclusions Longitudinal bleeding risks during treatment with DAPT in patients with ACS can be reliably predicted using selected baseline characteristics . The TRILOGY ACS bleeding models can inform risk –benefit considerations regarding the duration of DAPT following ACS . Trial registration Clinical Trials.gov identifier : https:// clinical BACKGROUND Low adiponectin levels are discussed as risk factor for cardiovascular events . This is of special importance in individuals with type 2 diabetes ( T2DM ) because they are at higher risk for cardiovascular diseases . The present study aim ed to investigate the effect of two plant oils rich in polyunsaturated fatty acids ( PUFA ) , with different content of omega-3 fatty acids , on adiponectin levels , glucose and lipid metabolism in T2DM individuals treated either with insulin or oral anti-diabetics ( OAD ) . METHODS Ninety-two subjects with T2DM [ 34 treated with insulin ( T2DM-Ins ) and 58 treated with OAD ( T2DM-OAD ) ] participated in this r and omised , double-blind , parallel intervention study . Individuals received either 9 g of nut oil ( n-3:n-6 ratio : 1.3 : 6.1 ) or mixed oil ( n-3:n-6 ratio : 0.6 : 5.7 ) per day for 10 weeks . The fatty acid profile , tocopherol , adiponectin levels and parameters regarding glucose and lipid metabolism were assessed at baseline , during and after the intervention . RESULTS Compliance was confirmed by significant increases in γ-tocopherol and PUFA in both oil groups . An increase in adiponectin levels in T2DM-Ins participants ( + 6.84 % in nut oil and + 4.47 % in mixed oil group after 10 weeks compared to baseline ) was observed , albeit not significantly different from T2DM-OAD individuals ( P = 0.051 ) . Lipid and glucose metabolism were not affected by the intervention . CONCLUSIONS The present study provides evidence that a small and easy change in dietary behaviour towards better fat quality moderately increases adiponectin levels in T2DM-Ins subjects , independently of the administered plant oil Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes ( T2DM ) . To contain the growing population of T2DM , it is critical to clarify effective and efficient setting s for intervention and modalities for intervention delivery with a wide population reach . The Japan Diabetes Outcome Intervention Trial-1 ( J-DOIT1 ) is a cluster r and omized controlled trial to test whether goal -focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting . This paper describes the study design and recruitment of the study subjects . Methods For the recruitment of study subjects and their follow-up annually over 3 years , we employed health checkups conducted annually at communities and worksites . Health care divisions recruited from communities and companies across Japan formed groups as a cluster r and omization unit . C and i date s for the study , aged 20 - 65 years with fasting plasma glucose ( FPG ) of 5.6 - 6.9 mmol/l , were recruited from each group using health checkups results in 2006 .  Goal -focused lifestyle support is delivered by healthcare providers via telephone over a one-year period . Study subjects will be followed-up for three years by annual health checkups . Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report , which is confirmed by referring to medical cards . Results Forty-three groups ( clusters ) , formed from 17 health care divisions , were r and omly assigned to an intervention arm ( 22 groups ) or control arm ( 21 clusters ) between March 2007 and February 2008 . A total of 2840 participants , 1336 from the intervention and 1504 from the control arm , were recruited .  Consent rate was about 20 % , with no difference between the intervention and control arms . There were no differences in cluster size and characteristics of cluster between the groups . There were no differences in individual characteristics between the study arms . Conclusion We have launched J-DOIT1 , a nation-wide trial to prevent the development of T2DM in high-risk individuals using telephone-delivered intervention . This trial is expected to contribute to evidence -based real-world preventive practice s . Trial registration UMIN000000662 Aims : DBCare ® ( Ace Continental Exports Inc. , London , UK ) is a traditional Indian herbal food supplement marketed as an antidiabetes remedy . This study evaluated the efficacy and safety of DBCare in patients with inadequately controlled type 2 diabetes mellitus ( T2DM ) despite oral hypoglycemic treatment . Methods : A 12-week r and omized double-blind placebo-controlled trial was conducted . Patients with T2DM on oral hypoglycemic agents with HbA1C > 7.0 % were r and omized to receive DBCare or placebo tablets . Results : Thirty-five patients ( 20 male/15 female ; mean age 61.2 ± 7.6 years ) , with a mean baseline HbA1C of 7.9 % ± 0.6 % , received DBCare ( N = 18 ) or placebo ( N = 17 ) . During the study period , HbA1C declined 0.4 ± 0.7 % in the DBCare ® group and 0.2 % ± 0.8 % in the placebo group ( p = 0.806 ) . No significant changes occurred in fasting plasma glucose , lipid profile , or homeostasis model assessment throughout the study or in body mass index , waist circumference , or blood pressure values . Hypoglycemic episodes ( glucose < 70 mg/dL ) were more frequent in the treatment group ( 7 vs 1 , p = 0.043 ) , necessitating a decrease in other hypoglycemic medications in 2 patients . DBCare was generally well tolerated , with mild side effects that were not different from those of the placebo group . Conclusions : This preliminary study did not demonstrate that DBCare was efficacious in improving glycemic control in inadequately controlled patients with T2DM on oral hypoglycemics . A trend toward improved glycemic control was noted in the DBCare group , which correlates with more frequent hypoglycemic episodes . Further studies are needed to eluci date DBCare 's hypoglycemic effect in patients with T2DM in general and in specific clinical setting s , such as HbA1C ≥ 8 % , short ( ≤10-year ) duration of diabetes , or young age in particular IMPORTANCE Adherence to cardioprotective medication regimens in the year after hospitalization for acute coronary syndrome ( ACS ) is poor . OBJECTIVE To test a multifaceted intervention to improve adherence to cardiac medications . DESIGN , SETTING , AND PARTICIPANTS In this r and omized clinical trial , 253 patients from 4 Department of Veterans Affairs medical centers located in Denver ( Colorado ) , Seattle ( Washington ) ; Durham ( North Carolina ) , and Little Rock ( Arkansas ) admitted with ACS were r and omized to the multifaceted intervention ( INT ) or usual care ( UC ) prior to discharge . INTERVENTIONS The INT lasted for 1 year following discharge and comprised ( 1 ) pharmacist-led medication reconciliation and tailoring ; ( 2 ) patient education ; ( 3 ) collaborative care between pharmacist and a patient 's primary care clinician and /or cardiologist ; and ( 4 ) 2 types of voice messaging ( educational and medication refill reminder calls ) . MAIN OUTCOMES AND MEASURES The primary outcome of interest was proportion of patients adherent to medication regimens based on a mean proportion of days covered ( PDC ) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications ( clopidogrel , β-blockers , 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [ statins ] , and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers [ ACEI/ARB ] ) . Secondary outcomes included achievement of blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) level targets . RESULTS Of 253 patients , 241 ( 95.3 % ) completed the study ( 122 in INT and 119 in UC ) . In the INT group , 89.3 % of patients were adherent compared with 73.9 % in the UC group ( P = .003 ) . Mean PDC was higher in the INT group ( 0.94 vs 0.87 ; P < .001 ) . A greater proportion of intervention patients were adherent to clopidogrel ( 86.8 % vs 70.7 % ; P = .03 ) , statins ( 93.2 % vs 71.3 % ; P < .001 ) , and ACEI/ARB ( 93.1 % vs 81.7 % ; P = .03 ) but not β-blockers ( 88.1 % vs 84.8 % ; P = .59 ) . There were no statistically significant differences in the proportion of patients who achieved BP and LDL-C level goals . CONCLUSIONS AND RELEVANCE A multifaceted intervention comprising pharmacist-led medication reconciliation and tailoring , patient education , collaborative care between pharmacist and patients ' primary care clinician and /or cardiologist , and voice messaging increased adherence to medication regimens in the year after ACS hospital discharge without improving BP and LDL-C levels . Underst and ing the impact of such improvement in adherence on clinical outcomes is needed prior to broader dissemination of the program . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00903032 BACKGROUND Type 2 diabetes mellitus ( T2DM ) is a disease associated with increased oxidative stress which results from mitochondrial dysfunction . Coenzyme Q10 ( CoQ10 ) is an essential antioxidant for energy production in mitochondria . The purpose of this r and omized double-blind clinical trial study was to evaluate the effects of CoQ10 supplementation on serum values of gamma-glutamyl transferase ( GGT ) , pseudocholinesterase ( PchE ) , bilirubin , ferritin , and high-sensitivity c-reactive protein ( hs-CRP ) and metabolic syndrome biomarkers in women with T2DM . MATERIAL & METHODS Eighty women with T2DM enrolled in this study . Thirty six of them were r and omized in the drug group ( receiving 100 mg/day of CoQ10 ) and 44 women were r and omized in placebo group . Intervention was continued for 12 weeks . In both groups 35 subjects finished the study and were included in the analysis . Serum levels of the variables were measured before and after supplementation . RESULTS Serum values of FBS ( P=0.039 ) , HOMA-IR ( P=0.01 ) , ferritin ( P<0.001 ) , total cholesterol ( TC ) ( P=0.006 ) , LDL-C ( P=0.007 ) decreased and HDL-C ( P=0.02 ) increased significantly in the drug group after intervention . Serum levels of triglyceride ( P=0.09 ) decreased marginally in CoQ10 group . CONCLUSIONS The results of the current study had shown that after supplementation with 100 mg/day of CoQ10 for 12 weeks , serum values of FBS , HOMA-IR , TC , LDL-C and ferritin were decreased and values of HDL-C were increased in women with T2DM BACKGROUND The literature suggests that people delay too long prior to attending emergency departments with acute coronary syndrome ( ACS ) symptoms . This delay is referred to as prehospital delay . Patient decision delay contributes most significantly to prehospital delay . OBJECTIVES Using a r and omized controlled trial , we tested an educational intervention to reduce patient prehospital delay in ACS and promote appropriate responses to symptoms . METHODS Eligible patients who were admitted across five emergency departments ( EDs ) in Dublin were recruited to the study ( n = 1944 ; control : 972 , intervention : 972 ) . RESULTS Median baseline prehospital delay times did not differ significantly between the groups at baseline ( Mann-Whitney U , p = 0.34 ) ( CONTROL : 4.28 h , 25(th ) percentile = 1.71 , 75(th ) percentile = 17.37 ; Intervention 3.96 h , 25(th ) percentile = 1.53 , 75(th ) percentile = 18.51 ) . Both groups received usual in-hospital care . In addition , patients r and omized to the intervention group received a 40-min individualized education session using motivational techniques . This was reinforced 1 month later by telephone . Of the 1944 , 314 ( 16.2 % ) were readmitted with ACS symptoms : 177 ( 18.2 % ) and 137 ( 14.1 % ) of the intervention and control groups , respectively . Prehospital delay times were again measured . Median delay time was significantly lower in the intervention compared to the control group ( 1.7 h vs. 7.1 h ; p ≤ 0.001 ) . Appropriately , those in the intervention group reported their symptoms more promptly to another person ( p = 0.01 ) and fewer consulted a general practitioner ( p = 0.02 ) . There was no significant difference in ambulance use ( p = 0.51 ) or nitrate use ( p = 0.06 ) between the groups . CONCLUSION It is possible to reduce prehospital delay time in ACS , but the need for renewed emphasis on ambulance use is important Background Type 2 diabetes mellitus ( T2DM ) is a disease with high prevalence , associated with severe co-morbidities as well as being a huge burden on public health . It is known that glycemic control decreases long-term morbidity and mortality . The current st and ard therapy for T2DM is medical treatment . Several r and omized controlled trials ( RCTs ) performed in obese patients showed remission of T2DM after bariatric surgery . Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese , insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM . This study aims at investigating whether Roux-en-Y gastric bypass ( RYGB ) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality . Methods The DiaSurg 2 trial is a multicenter , open r and omized controlled trial comparing RYGB including st and ardized medical treatment if needed to exclusive st and ardized medical treatment of T2DM ( control group ) . The primary endpoint is a composite time-to-event endpoint ( cardiovascular death , myocardial infa rct ion , coronary bypass , percutaneous coronary intervention , non-fatal stroke , amputation , surgery for peripheral atherosclerotic artery disease ) , with a follow-up period of 8 years . Insulin-dependent T2DM patients aged between 30 and 65 years will be included and r and omly assigned to one of the two groups . The experimental group will receive RYGB and , if needed , st and ardized medical care , whereas the control group will receive exclusive st and ardized medical care , both according to the national treatment guidelines for T2DM . Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population . Assuming a loss to follow-up rate of 20 % , 200 patients will be r and omly allocated to the comparison groups . A total sample size of n = 400 is sufficient to ensure 80 % power in a two-tailed significance test at alpha = 5 % . Discussion The DiaSurg2 trial will yield long-term data ( 8 years ) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or st and ardized medical care . Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004550 BACKGROUND Patients with acute , undifferentiated chest pain present a frequent diagnostic challenge to clinicians . Clinical features are often used to determine which patients may have acute coronary syndrome ( ACS ) . AIM To identify clinical features that independently predict ACS in patients with acute , undifferentiated chest pain . DESIGN Prospect i ve study of patients enrolled in a r and omized controlled trial . METHODS The presenting characteristics of participants in the ESCAPE r and omized trial of chest pain unit vs. routine care  were recorded in a st and ardized manner . Follow-up consisted of troponin T measurement at 2 days , postal question naire at 1 month , and telephone contact at 6 months . ACS was defined as elevated troponin T at 2 days or major adverse cardiac event within 30 days of presentation . Multivariate analysis identified independent clinical predictors of ACS . RESULTS ACS was diagnosed in 77 ( 7.9 % ) of the 972 patients recruited . The following characteristics were independent predictors of ACS ( odds ratio , p ) : age ( 1.09 , p < 0.001 ) , male gender ( 8.6 , p < 0.001 ) , indigestion or burning-type pain ( 3.0 , p = 0.034 ) , pain radiating to the left ( 2.4 , p = 0.013 ) or right ( 5.7 , p < 0.001 ) arm , vomiting ( 3.5 , p = 0.007 ) , and previous ( 5.1 , p < 0.001 ) or current ( 3.7 , p < 0.001 ) smoking . DISCUSSION In addition to previously recognized predictors of ACS , it appears that indigestion or burning type pain predicts ACS in patients attending the emergency department with acute , undifferentiated chest pain . Diagnosis of acute ' gastro-oesophageal ' chest pain should be avoided in this setting Background & objectives : India contributes a significant number of deaths attributed to coronary artery disease ( CAD ) compared to the rest of the world . Data on  catastrophic health expenditure ( CHE ) related to acute coronary syndrome ( ACS ) , the major cause of deaths in CAD , are limited in the literature . We estimated the magnitude of CHE and studied the strategies used to cope with CHE . Methods : Two hundred and ten ACS patients ( mean age 56 yr , 83 % men ) were r and omly selected proportionately from six hospitals in Thiruvananthapuram district , Kerala , India . Information on demographics , ACS-related out-of-pocket expenditure and coping strategies was collected using a pre-tested structured interview schedule . CHE , defined as ACS-related expenditures exceeding 40 per cent of a household 's capacity to pay , was estimated using the World Health Organization methods . Health security was defined as protection against out-of-pocket expenditure through an employer or government provided social security scheme . Socio-demographic variables , effect on participants ’ employment , loans or asset sales for treatment purpose s , health security coverage and type of treatment were considered as potential correlates of CHE . Multiple logistic regression analyses were conducted to identify the correlates of CHE . Results :  CHE  was experienced by 84 per cent ( 95 % CI : 79.04 , 88.96 ) of participants as a consequence of treating ACS . Participants belonging to low socio-economic status ( SES ) were 15 times ( odds ratio ( OR ) : 14.51 , 95 % CI : 1.69 - 124.41 ) , whose jobs were adversely affected were seven times ( OR : 7.21 , CI : 1.54 - 33.80 ) , who had no health security were six times ( OR : 6.00 , CI : 2.02 - 17.81 ) and who underwent any intervention were three times ( OR : 3.24 , CI : 1.03 - 10.16 ) more likely to have CHE compared to their counterparts . The coping strategies adopted by the participants were loans ( 41 % ) , savings ( 14 % ) , health insurance ( 8 % ) and a combination of the above ( 37 % ) . Interpretation & conclusions : Our findings show that viable financing mechanism for treating ACS is warranted to prevent CHE particularly among low SES participants , those having no health security , requiring intervention procedures and those with adversely affected employment
Nurses only and multidisciplinary teams were the most frequent professionals to provide education , and most educational interventions were delivered postdischarge .
Psychoeducational interventions were generally effective at reducing smoking and admissions for patients with ACS .
Culturally appropriate health education , self-management educational interventions , group medical visits and psychoeducational interventions were generally effective for patients with T2DM .
Results indicate that there is a body of current evidence about the efficacy of health education , its content and delivery methods for patients with ACS or T2DM .
OBJECTIVES This umbrella review aim ed to identify the current evidence on health education-related interventions for patients with acute coronary syndrome ( ACS ) or type two diabetes mellitus ( T2DM ) ; identify the educational content , delivery methods , intensity , duration and setting required .
The purpose was to provide recommendations for educational interventions for high-risk patients with both ACS and T2DM .