Improvement in glycemic control by gastric electrical stimulation (TANTALUSTM) in overweight subjects with type 2 diabetes Implantable gastric stimulation to achieve weight loss in patients with a low body mass index Retrograde Gastric Pacing Reduces Food Intake and Delays Gastric Emptying in Humans: A Potential Therapy for Obesity? Fasting plasma triglycerides predict the glycaemic response to treatment of Type 2 diabetes by gastric electrical stimulation. A novel lipotoxicity paradigm Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Gastric Electrical Stimulation with the TANTALUS® System in Obese Type 2 Diabetes Patients: Effect on Weight and Glycemic Control The TANTALUS™ System for Obesity: Effect on Gastric Emptying of Solids and Ghrelin Plasma Levels Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device. Intra-abdominal vagal blocking (VBLOC therapy): clinical results with a new implantable medical device. Treatment of morbid obesity by intraparietogastric administration of botulinum toxin: a randomized, double-blind, controlled study “What are the Yanks Doing?” The U.S. Experience with Implantable Gastric Stimulation (IGS) for the Treatment of Obesity — Update on the Ongoing Clinical Trials Improvement in Glycemic Control in Morbidly Obese Type 2 Diabetic Subjects by Gastric Stimulation Effect of Intestinal Pacing on Small Bowel Transit and Nutrient Absorption in Healthy Volunteers The Effect on Gastric Tone of Gastric Electrical Stimulation with Trains of Short Pulses Varies with Sites and Stimulation Conditions Gastric Pacing as Therapy for Morbid Obesity: Preliminary Results Evolution of Glycolipid Profile After Sleeve Gastrectomy vs. Roux-en-Y Gastric Bypass: Results of a Prospective Randomized Clinical Trial Progress in Implantable Gastric Stimulation: Summary of Results of the European Multi-Center Study Gastric Electrical Stimulation Using Endoscopically Placed Mucosal Electrodes Reduces Food Intake in Humans Visceral response to acute retrograde gastric electrical stimulation in healthy human. Gastric electrical stimulation as therapy of morbid obesity: preliminary results from the French study. One-Year Experience with Tantalus™: a New Surgical Approach to Treat Morbid Obesity The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity
Background The TANTALUS system ( MetaCure Ltd. ) is a minimally invasive implantable gastric stimulation modality that does not exhibit malabsorptive or restrictive characteristics . The device applies gastric contractility modulation ( GCM ) signals to the stomach antrum . The signals are delivered in synchronization to the native electrical activity of the stomach during meals . Retrospective analysis of previous studies indicated that type 2 diabetes mellitus ( T2DM ) subjects on oral medication with hemoglobin A1c ( HbA1c ) between 7.5 % and 9.5 % are the population with most potential benefit from the treatment . The current study includes subjects enrolled prospect ively within that range of HbA1c . Aim To prospect ively investigate the potential effect of the TANTALUS system on glycemic control and weight in overweight subjects with T2DM . Methods In this European multicenter , open-label study , 13 T2DM obese ( 6 male , 7 female , BMI 37.2 ± 1.0 kg/m2 , range 30.4–44.0 kg/m2 ) subjects treated with oral antidiabetic medications but with poor glycemic control ( HbA1c ≥ 7 % , range 7.3–9.5 % ) were implanted laparoscopically with the TANTALUS system . Results Thirteen subjects that had completed 3 months of treatment showed a significant reduction in HbA1c from 8.0 ± 0.2 % to 6.9 ± 0.1 % ( p < 0.05 ) , whereas fasting blood glucose decreased from 175 ± 6 mg/dL to 127 ± 8 mg/dL ( p < 0.05 ) . The glycemic improvement was accompanied by reduction in weight from 104.4 ± 4.4 kg to 99.7 ± 4.8 kg , and in waist circumference from 122.3 ± 3.2 cm to 117.0 ± 3.0 cm . Conclusions Interim results with the TANTALUS system suggest that this stimulation regime can potentially improve glucose levels and induce moderate weight loss in obese T2DM subjects on oral antidiabetic therapy with poor glycemic control . Further evaluation is required to determine whether this effect is due to induced weight loss and /or due to direct signal-dependent mechanisms This report describes the authors ’ early outcomes with implantable gastric stimulation ( IGS ) used to achieve weight loss in patients with a low body mass index ( BMI ) . After prescreening of potential c and i date s with a selection algorithm , 24 patients ( 21 women and 3 men ) with a low BMI ( 30–34.9 ) underwent IGS implantation at two centers . The patients had a mean age of 43 years ( range , 32–60 years ) , a mean BMI of 33 ( range , 30–36 ) , and a mean weight of 92 kg ( range , 80–117 kg ) . At this writing , 6 months postoperatively , there have been no serious adverse events related to the device . The mean percentage of excess weight loss ( EWL ) was 5.9 % , with three patients explanted because of noncompliance . The mean waist circumference decreased 5.8 % , which was significant ( p = 0.009 ) . A subset of nine patients ( 37.5 % ) had an EWL exceeding 10 % ( mean , 20.1 % ) . A subset of low BMI patients lost a clinical ly significant amount of weight with IGS within 6 months . Further study is required for better identification of potential c and i date s for this novel approach Obesity is one of the most prevalent health problems in the world with a lack of satisfactory therapies and gastric electrical stimulation has recently been proposed for the treatment of obesity . The aim of this study was to investigate the effects of retro grade gastric pacing ( RGP ) on food and water intake , and gastric emptying in humans .  RGP with a tachygastrial frequency of 9 cycles/min was performed via a pair of submucosal gastric electrodes implanted 5 cm above the pylorus in 12 subjects . The water load test , food intake test and scintigraphic gastric emptying test were performed to assess the efficacy of RGP . RGP result ed in a 13 % reduction in the consumption of water , a 16 % reduction in food intake and a 15 % increase in gastric retention of a solid meal . No significant symptoms were recorded with RGP using the parameters used for the water-load , food intake and scintigraphic gastric emptying tests . Acute RGP at a tachygastrial frequency results in a significant reduction of water and food intake and a delay in gastric emptying without inducing any unacceptable symptoms . It is worthy to explore its therapeutic potential for obesity Background Non-stimulatory , meal-mediated electrical stimulation of the stomach ( TANTALUS-DIAMOND ) improves glycaemic control and causes modest weight loss in patients with Type 2 diabetes who are inadequately controlled on oral anti-diabetic medications . The magnitude of the glycaemic response in clinical studies has been variable . A preliminary analysis of data from patients who had completed 6 months of treatment indicated that the glycaemic response to the electrical stimulation was inversely related to the baseline fasting plasma triglyceride level . Method An analysis of 40 patients who had had detailed longitudinal studies for 12 months . Results Twenty-two patients with fasting plasma triglycerides ≤ 1.7 mmol/l had mean decreases in HbA1c after 3 , 6 and 12 months of gastric contraction modulation treatment of −15 ± 2.1 mmol/mol ( −1.39 ± 0.20 % ) , −16 ± 2.2 mmol/mol ( −1.48 ± 0.20 % ) and −14 ± 3.0 mmol/mol ( −1.31 ± 0.26 % ) , respectively . In contrast , 18 patients with fasting plasma triglyceride > 1.7 mmol/l had mean decreases in HbA1c of −7 ± 1.7 mmol/mol ( −0.66 ± 0.16 % ) , −5 ± 1.6 mmol/mol ( −0.44 ± 0.18 % ) and −5 ± 1.7 mmol/mol ( −0.42 ± 0.16 % ) , respectively . Pearson 's correlation coefficient between fasting plasma triglyceride and decreases in HbA1c at 12 months of treatment was 0.34 ( P < 0.05 ) . Homeostasis model assessment of insulin resistance was unchanged during 12 months of treatment in patients with high baseline fasting triglycerides , while it progressively improved in patients with low fasting plasma triglycerides . Patients with low fasting plasma triglycerides had a tendency to lose more weight than those with high fasting plasma triglycerides , but this did not achieve statistical significance . Conclusions The data presented suggest the existance of a triglyceride lipotoxic mechanism that interferes with gastric/neural mediated pathways that can regulate glycaemic control in patients with type 2 diabetes . The data suggest the existence of a triglyceride lipotoxic pathway that interferes with gastric/neural mediated pathways that can regulate glycaemic control BACKGROUND To compare implantable gastric stimulation therapy with a st and ard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss ( EWL ) between the control and treatment groups . The primary endpoint was the percentage of EWL from baseline to 12 months after r and omization . Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients ; however , previous investigations have reported inconclusive results . METHODS A total of 190 subjects were enrolled in this prospect i ve , r and omized , placebo-controlled , double-blind , multicenter study . All patients underwent implantation with the implantable gastric stimulator and were r and omized to 1 of 2 treatment groups : the control group ( stimulation off ) or treatment group ( stimulation on ) . The patients were evaluated on a monthly basis . All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings . RESULTS The procedure result ed in no deaths and a low complication rate . The primary endpoint of a difference in weight loss between the treatment and control groups was not met . The control group lost 11.7 % + /- 16.9 % of excess weight and the treatment group lost 11.8 % + /- 17.6 % ( P = .717 ) according to an intent-to-treat analysis . CONCLUSION Implantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations . However , the results of the present study do not support its application . Additional research is indicated to underst and the physiology and potential benefits of this therapy Background : The TANTALUS ® System is an investigational device that consists of an implantable pulse generator connected to gastric electrodes . The system is design ed to automatically detect when eating starts and only then deliver sessions of gastric electrical stimulation ( GES ) with electrical pulses that are synchronized to the intrinsic antral slow waves . We report the effect of this type of GES on weight loss and glucose control in overweight/obese subjects with type 2 diabetes mellitus ( T2DM ) . This study was conducted under a Food and Drug Administration/Institutional Review Board-approved investigational device exemption . Method : Fourteen obese T2DM subjects on oral antidiabetes medication were enrolled and implanted laparoscopically with the TANTALUS System ( body mass index 39 ± 1 kg/m2 , hemoglobin A1c [ HbA1c ] 8.5 ± 0.2 % ) . Gastric electrical stimulation was initiated four weeks after implantation . Weight , HbA1c , fasting blood glucose , blood pressure , and lipid levels were assessed during the study period . Results : Eleven subjects reached the 6-month treatment period endpoint . Gastric electrical stimulation was well tolerated by all subjects . In those patients completing 6 months of therapy , HbA1c was reduced significantly from 8.5 ± 0.7 % to 7.6 ± 1 % , p < .01 . Weight was also significantly reduced from 107.7 ± 21.1 to 102.4 ± 20.5 kg , p < .01 . The improvement in glucose control did not correlate with weight loss ( R 2 = 0.05 , p = .44 ) . A significant improvement was noted in blood pressure , triglycerides , and cholesterol ( low-density lipoprotein only ) . Conclusions : Short-term therapy with the TANTALUS System  improves glucose control , induces weight loss , and improves blood pressure and lipids in obese T2DM subjects on oral antidiabetes therapy Background Gastric electrical stimulation ( GES ) , using the implantable TANTALUSTM System , is being explored as a treatment for obesity . The system delivers nonstimulatory electrical signals synchronized with gastric slow waves , result ing in stronger contractions . We hypothesized that this GES may enhance gastric emptying and as a result affect plasma ghrelin and insulin homeostasis . The aim was to test the effect of GES on gastric emptying of solids and on ghrelin and insulin blood levels in obese subjects . Methods The system consists of 3 pairs of gastric electrodes connected to an implantable pulse generator . Gastric emptying test  ( GE ) of solids was performed twice , on separate days , a few weeks after implantation , before and after initiation of stimulation . Blood sample s for ghrelin and insulin were taken at baseline and at 15 , 30 , 60 and 120 min after the test meal . Results There were 11 females , 1 male , mean age 39.1 ± 8.9 years , mean BMI 41.6 ± 3.4 . Data is available from 11 subjects ; GE was normal in 9 subjects and accelerated in 2 subjects  . GES significantly accelerated GE compared to control : percent retention at 2 hours 18.7 ± 12.2 vs 31.9 ± 16.4 , respectively ( P < 0.01 ) . Overall , there was no significant change in ghrelin or insulin profile after food intake . Ghrelin levels fell significantly at 60 min compared to baseline during stimulation ( P = 0.014 ) and control ( P = 0.046 ) . Conclusion GES results in a significant acceleration of gastric emptying of solids in obese subjects . GES did not have a significant effect on postpr and ial ghrelin levels when compared to control BACKGROUND A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss ( EWL ) in an initial clinical trial in obese patients . The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia , Norway , and Switzerl and . METHODS Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms . In the second trial , vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device . The patients were followed up for 6 months to assess the EWL and safety , including adverse events . RESULTS In the initial clinical trial , vagal blocking algorithm duration s of 90 - 150 s were associated with greater EWL compared with either shorter or longer algorithm duration s ( P<.01 ) . The second trial enrolled 27 patients ( mean body mass index 39.3+/-.8 kg/m2 ) to evaluate a 120-s blocking algorithm . At 6 months , greater EWL was achieved ( 22.7%+/-3.1 % , n=24 ) compared with the initial study and first-generation device ( 14.2%+/-2.2 % , n=29 , P=.03 ) . In both trials , an association was found between the number of 90 - 150-s algorithms delivered daily and greater EWL ( P=.03 ) . No deaths , unanticipated device-related adverse events , or medically serious adverse events were associated with the device . CONCLUSION This second-generation vagal blocking device , using a therapy algorithm of 120-s duration , result ed in a clinical ly acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm duration BACKGROUND A new medical device uses high-frequency electrical algorithms to create intermittent vagal blocking ( VBLOC therapy ) . The aim is to assess the effects of vagal blocking on excess weight loss ( EWL ) , safety , dietary intake , and vagal function . METHODS An open-label , 3-center study was conducted in obese subjects ( body mass index [ BMI ] 35 - 50 kg/m(2 ) ) .  Electrodes were implanted laparoscopically on both vagi near the esophagogastric junction to provide electrical block . Patients were followed for 6 months for body weight , safety , electrocardiogram , dietary intake , satiation , satiety , and plasma pancreatic polypeptide ( PP ) response to sham feeding . To specifically assess device effects alone , no diet or exercise programs were instituted . RESULTS Thirty-one patients ( mean BMI , 41.2 + /- 1.4 kg/m(2 ) ) received the device .  Mean EWL at 4 and 12 weeks and 6 months after implant was 7.5 % , 11.6 % , and 14.2 % , respectively ( all P < .001 ) ; 25 % of patients lost > 25 % EWL at 6 months ( maximum , 36.8 % ) . There were no deaths or device-related serious adverse events ( AEs ) . Calorie intake decreased by > 30 % at 4 and 12 weeks and 6 months ( all P < or= .01 ) , with earlier satiation ( P < .001 ) and reduced hunger ( P = .005 ) . After 12 weeks , plasma PP responses were suppressed ( 20 + /- 7 vs 42 + /- 19 pg/mL ) . Average percent EWL in patients with PP response < 25 pg/mL was double that with PP response > 25 pg/mL ( P = .02 ) . Three patients had serious AEs that required brief hospitalization , 1 each for lower respiratory tract , subcutaneous implant site seroma , and Clostridium difficile diarrhea . CONCLUSIONS Intermittent , intra-abdominal vagal blocking is associated with significant EWL and a desirable safety profile Objective : The stomach is the main target organ for bariatric surgery , but no medical treatment has been developed to increase satiety and decrease food intake via gastric pathways . The aim of our study was to investigate whether or not the intraparietogastric administration of botulinum toxin A ( BTX ) , able to modify the motility patterns of the stomach , could be useful for treatment of obesity . Design : Double blind controlled study .Subjects : Twenty-four morbidly obese patients ( mean weight ( s.e.m . ) 116.1±4.89 kg , mean body mass index ( BMI ) 43.6±1.09 kg/m2 ) were blindly r and omized to receive 200 IU BTX or placebo into the antrum and fundus of the stomach by intraparietal endoscopic administration . Measurements : We evaluated weight loss , BMI changes , satiety score , the maximal gastric capacity for liquids and the gastric emptying time ( octanoic acid breath test ) . Results : The two groups were homogeneous for anthropometric characteristics . Eight weeks after treatment , BTX patients had significantly higher weight loss ( 11±1.09 vs 5.7±1.1 kg , P<0.001 ) and BMI reduction ( 4±0.36 vs 2±0.58 kg/m2 , P<0.001 ) and a higher satiety score on a visual analogic scale ( 7.63±0.38 vs 4.72±0.44 , P<0.001 ) than controls . Furthermore , BTX patients showed a significantly greater reduction in maximal gastric capacity for liquids ( 266.6±48 vs 139±31 , P<0.001 ) and a greater prolongation in gastric emptying time ( + 18.93±8 vs −2.2±6.9 min , P<0.05 ) . No significant side effects or neurophysiologic changes were found . Conclusions : Topical intragastric BTX was effective in reducing food intake and body weight in morbidly obese patients En Abstract Background The prevalence of obesity is growing worldwide . Medical therapies are often ineffective , and surgical treatments have significant risk . IGS ® offers a novel approach to weight loss that was found to be safe and effective in European trials . In the U.S. , 2 consecutive trials have been undertaken . Methods In 2000 , a multicenter , prospect i ve , r and omized , placebo-controlled trial involving 103 morbidly obese patients ( U.S. O-01 ) was undertaken . In 2002 , a prospect i ve , open label trial involving 30 morbidly obese patients was initiated ( DIGEST ) . Patients were followed for complications , postoperative untoward events , and weight loss . Results In O-01 , there were no significant perioperative complications . However , 20 patients were found to have had lead dislodgements . At 7 months , there was no significant difference in weight loss between the activated and non-activated groups . After 29 months , loss of excess weight ( EWL ) approached 20 % . With DIGEST , there was 1 operative complication ( a lost needle retrieved surgically ) . There were no untoward events or known lead dislodgements . EWL was 23 % after only 16 months follow-up . With the introduction of a preoperative screening algorithm , almost 40 % EWL was achieved for selected patients in both trials . Conclusions In the U.S. , the IGS system for the treatment of obesity has been shown to be safe . Technical improvements and better patient selection result ed in improved weight loss . The preliminary results of these trials suggest that IGS may be a suitable surgical option for selected patients Background Gastric electrical stimulation synchronized to the refractory period of gastric electrical activity and applied during meals was evaluated for safety and for improvement of body weight and glycemic control in obese type 2 diabetes . Methods The study involved obese diabetic type 2 ( ODM ) patients in a multicenter open-label European feasibility trial . A total of 24 ODM ( nine males , 15 females ) treated with insulin and /or oral hyperglycemic agents and body mass index between 33.3 to 49.7 kg/m2 were implanted laparoscopically with a TANTALUS system . Results There were 18 adverse events related to the implant procedure or the device reported in 12 subjects . All were short lived and resolved with no sequelae . In the 21 subjects that reached the 1-year visit weight was reduced by 4.5 ± 2.7 kg ( p < 0.05 ) and HbA1c by 0.5 ± 0.3 % ( p < 0.05 ) . In a subgroup ( n = 11 ) on stable or reduced oral medication , weight was reduced by 6.3 ± 3.4 kg ( p < 0.05 ) and HbA1c by 0.9 ± 0.4 % ( p < 0.05 ) . The group on insulin ( n = 6 ) had no significant changes in weight and HbA1c . Conclusions The TANTALUS system is well tolerated in obese type 2 diabetic subjects . Gastric electrical stimulation can potentially improve glucose metabolism and induce weight loss in obese diabetic patients , who are not well controlled on oral antidiabetic therapy . Further evaluation is required to determine whether this effect is due to induced weight loss and /or to direct signal dependent mechanisms Background Intestinal pacing ( IP ) has been previously shown to delay gastric emptying and reduce food intake in animals . The aims of this study were to investigate the effect and mechanism of IP on nutrient absorption in healthy volunteers . Methods Twelve healthy volunteers ( six men , six women ) were involved in a two-session ( one session without IP and one with IP ) study . At the beginning of each session , a nasal-duodenal feeding tube , with two ring electrodes ( used for IP ) on the tip of the tube , was incubated into the duodenum under endoscopy . After a complete recovery from the incubation , the duodenum was infused via the feeding tube with 150 ml 30 % intralipid + 25 g D-xylose within 30 min , and the stool was collected for 24 h for the analysis of fecal lipid during which a controlled meal was taken . Then 100 ml 1mCi99Tc-labeled non-absorbable solution was infused within 3 min . The subject was asked to lie under a γ camera for at least 1 h for the measurement of small bowel transit . The movement of isotopes was monitored by γ camera at an interval of 10 s. The first appearance of isotopes in the cecum was considered as small intestinal transit time . The order of the two sessions was r and omized and 1 week apart . In the IP session , intestinal pacing was performed via the pair of the ring electrodes for 2 h initiated at the beginning of infusion with a pacing frequency of 13 pulses/min , pulse width of 300 ms and amplitude of 5 mA. Results ( 1 ) IP significantly reduced lipid and D-xylose absorption . The fecal lipid was 6.6 ± 4.6 g without IP and almost doubled with IP ( 11.1 ± 6.5 g , P = 0.047 ) . Similarly , the D-xylose in urine was 3.46 ± 2.22 g with IP , which was significantly lower than that without IP ( 6.63 ± 5.06 g , p = 0.049 ) . ( 2 ) IP accelerated intestinal transit . The transit time was 39 ± 17 min in the control session and reduced to 28 ± 10 min in the IP session ( p < 0.03 ) . ( 3 ) Diarrhea was reported in one subject without IP but in six subjects with IP ( p < 0.05 ) . Conclusions The increased fecal lipid and induction of diarrhea with intestinal pacing suggest that intestinal pacing is capable of inducing malabsorption . This effect maybe contributed to the acceleration of intestinal transit Background Gastric electrical stimulation ( GES ) can improve symptoms in patients with gastroparesis and induce weight loss in obese subjects . Aims To evaluate the effect on gastric tone of GES under different conditions at different sites of the stomach . Methods Eleven dogs were implanted with a gastric cannula and two pairs of stimulation electrodes ( in the middle of the lesser curvature and of the greater curvature , 10 cm from the pylorus ) . Gastric tone was assessed with a barostat . GES was applied using : ( 1 ) Enterra conditions ( 14 Hz , 5 mA , 0.3 ms , 0.1 s on , 5 s off ) ; ( 2 ) modified Enterra conditions ( 40 Hz , 5 mA , 0.3 ms , 0.1 s on , 5 s off ) ; and ( 3 ) implantable gastric stimulation ( IGS ) conditions ( 40 Hz , 5 mA , 0.3 ms , 2 s on , 3 s off ) . Six sessions were performed r and omly with each animal on six separate days . Results ( 1 ) At the lesser curvature , GES with modified Enterra conditions significantly elevated gastric volume from 96.9 ± 8.3 ml at baseline to 133.9 ± 11.7 ml ( P = 0.015 ) and a similar effect was observed with IGS ( 91.3 ± 7.1 ml vs. 186.3 ± 27.1 ml , P = 0.013 ) . GES with Enterra conditions had no such an effect . ( 2 ) At the greater curvature , GES with Enterra conditions significantly increased gastric volume from basal 94.1 ± 4.4 ml to 122.1 ± 11.3 ml ( P = 0.032 ) ; modified Enterra conditions had the opposite effect ( 96.5 ± 9.0 ml vs. 77.4 ± 11.7 ml , P = 0.025 ) and no significant effect was observed with IGS conditions . Conclusion The effects of GES  on gastric tone vary with the conditions and sites of stimulation . These findings may help to explain the distinct effects of GES therapy in patients with gastroparesis and obesity En Abstract Background A novel method to treat morbid obesity is presented — gastric electrical pacing . Following animal research , human investigation in a total of 24 patients in three cohorts began in 1995 . Methods Morbidly obese subjects ( BMI ≥40 ) received electrical stimulation devices  in 1995/6 ( n=4 ) , 1998 ( n=10 ) and 2000 ( n=10 ) . Electrodes were positioned intramuscularly on the anterior gastric wall at the lesser curvature . BMI = body mass index ; % EBL = % excess BMI ( > 25 ) lost . Results Patients reported satiety for food with less food . The 2 patients from the first study followed for > 5 years have achieved 38 and 67 % EBL . In the second study , every patient lost weight . At 36 months follow-up , the mean % EBL was 24±10 SD ( n=10 ) . Conclusions Implantable gastric pacing is a safe procedure and causes changes in eating habits in morbidly obese humans , result ing in decreased food intake and weight loss Background This study aims to report glycolipid changes after  sleeve gastrectomy ( SG ) or Roux-en-Y gastric bypass ( RYGB )  in the setting of a prospect i ve r and omized clinical trial . Methods One hundred patients were r and omly assigned to RYGB ( n = 45 ) and SG ( n = 55 )  . Fasting glucose , insulin , glycated hemoglobin ( HbA1c% ) , triglycerides , and serum cholesterol ( total , HDL , and LDL ) were evaluated at inclusion and after 1 , 3 , 6 , and 12 months . The index for homeostasis model assessment of insulin resistance ( HOMA-IR ) and β cell function ( HOMA-B ) were assessed . Results Mean postoperative 1- , 3- , 6- , and 12-month excess weight loss was 25.39 , 43.47 , 63.75 , and 80.38 % after RYGB and 25.25 , 51.32 , 64.67 , and 82.97 % after SG , respectively . Mean fasting glucose and fasting serum insulin were similarly and statistically significantly reduced in both RYGB and SG . Mean HOMA-IR improved in both groups , particularly in case of high preoperative values , and mean HOMA-B improved at 1 year after RYGB . HbA1c% dropped from 5.66 % ( SD = 0.61 ) to 5.57 % ( SD = 0.32 ) after RYGB and from 5.64 % ( SD = 0.43 ) to 5.44 % ( SD = 0.43 ) after SG . Total cholesterol was significantly higher at 1 month ( p = 0.04 ) , 3 months ( p = 0.03 ) , and 1 year ( p = 0.005 ) after SG as compared to RYGB . LDL cholesterol decreased significantly after RYGB at 1 month ( p = 0.03 ) , 3 months ( p = 0.0001 ) , and 1 year ( p = 0.0004 ) as compared to SG . HDL cholesterol was increased at 1 year in the RYGB group but not in the SG group . Triglycerides decreased similarly in both groups . Conclusions Short-term glycemic control was comparable after SG and RYGB . An improved lipid profile was noted after RYGB in patients with abnormal preoperative values Background The Implantable Gastric Stimulator ( IGS ® ) , a pacemaker-like device , has been found to be safe and effective to induce and maintain weight loss . The LOSS ( Laparoscopic Obesity Stimulation Survey ) is a prospect i ve non-r and omized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries . In 19 patients , ghrelin was analyzed . Methods Between January 2002 and December 2003 , 69 patients ( F/M 49/20 ) , mean age 41 years ( 18–65 ) underwent IGS implantation .  Mean BMI was 41 ( 35–57 ) , mean weight 115.0 kg ( 65–160 ) and mean excess weight ( EW ) 52 kg ( 13–89 ) . The IGS was actived 30 days after implantation . In a subset of 19 patients studied further , 0 , 6 , and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed . Results The mean ± st and ard error % EWL was : 8.6±1.8 at 1 month , 15.8±2.3 at 3 months , 17.8±2.6 at 6 months , 21.0±3.5 at 10 months , and 21.0±5.0 at 15 months . There were no intraoperative surgical or long-term complications . 7 intra-operative gastric penetrations occurred , observed by gastroscopy , without sequelae . 1 patient required a reoperation to remove a retained lead needle . In the subset of 19 patients , appetite was reduced and post-pr and ial and inter-pr and ial satiety was increased after IGS implantation . In the 19 patients , despite weight reduction , ghrelin did not increase . Conclusion IGS can be implanted laparoscopically with minimal perioperative complications . Appetite is reduced and satiety is increased after the implantation . Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients . If weight loss is maintained , IGS could be considered a good option for selected patients BACKGROUND : Implantable gastric stimulation ( IGS ) has been proposed for treating obesity . The aim of this study was to investigate the effects of temporary mucosal electrical stimulation on water and food intake as well as gastric emptying in healthy humans . METHODS : The study was design ed to study the effects of temporary gastric electrical stimulation ( GES ) on symptoms , gastric accommodation , food intake , and gastric emptying . It was performed in 12 healthy volunteers on 3 consecutive days . GES was performed using mucosal electrodes endoscopically placed in the fundus . RESULTS : The amount of maximum water intake was reduced with GES ( 894 ± 326 mL ) compared with sham-GES ( 1,093 ± 417 mL , p= 0.01 ) . The food intake was also reduced with GES ( p= 0.012 ) . In comparison with sham stimulation , GES  delayed gastric emptying during the first 45 min after the meal but not during the remaining time . GES with parameters effective in reducing water and food intake and delaying gastric emptying did not induce significant dyspeptic symptoms , compared with sham stimulation . CONCLUSIONS : GES using temporary mucosal electrodes decreases food intake as well as maximum intake of water , and has a tendency of delaying gastric emptying . It may have a potential application for the treatment of obesity AIM To investigate the visceral response to acute retro grade gastric electrical stimulation ( RGES ) in healthy humans and to derive optimal parameters for treatment of patients with obesity . METHODS RGES with a series of effective parameters were performed via a bipolar mucosal electrode implanted along the great curvature 5 cm above pylorus of stomach in 12 healthy human subjects . Symptoms associated with dyspepsia and other discomfort were observed and grade d during RGES at different setting s , including long pulse and pulse train . Gastric myoelectrical activity at baseline and during different setting s of stimulation was recorded by a multi-channel electrogastrography . RESULTS The gastric slow wave was entrained in all the subjects at the pacing parameter of 9 cpm in frequency , 500 ms in pulse width , and 5 mA in amplitude . The frequently appeared symptoms during stimulation were satiety , bloating , discomfort , pain , sting , and nausea . The total symptom score for each subject significantly increased as the amplitude or pulse width was adjusted to a higher scale in both long pulse and pulse train . There was a wide diversity of visceral responses to RGES among individuals . CONCLUSION Acute RGES can result in a series of symptoms associated with dyspepsia , which is beneficial to the treatment of obesity . Optimal parameter should be determined according to the individual sensitivity to electrical stimulation BACKGROUND Gastric electrical stimulation to treat morbid obesity , using the Transcend Implantable Gastric Stimulator ( IGS ) , is being evaluated . We present our preliminary results from the French segment of the worldwide study to evaluate this therapy . METHODS Institutionally-approved informed consent was obtained from all patients . The IGS is placed laparoscopically . The system has two implantable components : 1 ) a lead with two electrodes that is implanted in a gastric lesser curvature muscle tunnel ; 2 ) the lead is connected to an electrical pulse generator positioned subcutaneously on the abdominal wall . Two electrode positions were used ; half ( 6/12 , 50 % ) were " low " near the pes anserinus , and the other 50 % " high " nearer the esophagogastric junction . Intraoperative gastroscopy is used to diagnose inadvertent gastric perforation . 12 patients ( 5 M , 7 F ) had the IGS implanted between July 2000 and February 2001 . Mean age was 40.6 years ( 31 - 51 ) . Mean weight was 122.2 kg ( 93 - 146 ) , mean BMI was 42.7 kg/m2 ( 39.1 - 48.6 ) , and mean excess weight was 60 kg ( 42 - 74 ) . Electrical stimulation commenced 1 month after implantation . RESULTS All devices were successfully placed laparoscopically . There were no deaths or major operative complications . Postoperative course was uneventful in all cases . In 25 % ( 3/12 ) , postoperative lead dislodgement occurred ; 2 of the 3 had their leads replaced . By 9 months , mean excess BMI lost was 30 + /- 24 % or 16 + /- 12 kg . CONCLUSION Implanting the IGS to treat morbid obesity is technically feasible and safe . Lead dislodgement has been simply and satisfactorily corrected . Satisfactory short-term weight loss has been achieved in a subset of patients . Long-term efficacy must now be determined Background : Increased caloric density in modern processed foods may be an important factor underlying the prevalence of obesity , because low-volume , high-caloric food intake may delay activation of volume-dependent gastric mechanical activity known to induce the feeling of fullness . We therefore hypothesized that enhancement of gastric contractions by electrical stimulation at an early stage of the meal will reduce food intake and body weight in morbidly obese subjects . Methods : The study was a prospect i ve , non-r and omized , open-label , single-center trial . 12 subjects ( age 36.1 ± 2.8 years , BMI 43.2 ± 2.7 kg/m2 , weight 128.8 ± 5.2 kg , means±SEM ) underwent laparoscopic implantation with the Tantalus ™ system . A pulse generator with 3 bipolar leads was implanted : 2 pairs in the antrum and a 3rd pair in the fundus . The system was activated at week 6 . All subjects were followed for 20 weeks and 9 of them for 52 weeks . Results : All subjects finished the initial 20-week observation period . Following activation of the Tantalus ™ System , a reduction ( P<0.05 ) in hunger and an increase in cognitive control ( P<0.05 ) as assessed by the Three-Factor Eating Question naire ( TFEQ ) could be observed . Body weight decreased ( P<0.05 ) from 128.8±5.2 to 119.9 + 5.9 ( 17.6 + 4.3 % EWL , N=12 ) after 20 weeks ( 14 weeks of treatment ) . In the 9 subjects continuing for 52 weeks ( 46 weeks of treatment ) , body weight further decreased to 112.4 ± 3.8 kg ( 26.6 ± 8.5 % EWL , N=9 ) . Blood pressure decreased ( P<0.05 ) from 142 ± 6.1/91 ± 3.2 to 125.5 ± 4.0/83 ± 2.6 mmHg by week 20 and 128.8 ± 3.8 / 86.3 ± 3.6 mmHg after 1 year . The frequency and severity of device and /or procedure-related adverse events indicate that the method is safe and well-tolerated . Conclusion : This data suggests that gastric stimulation by the minimally invasive Tantalus ™ System is safe and leads to favorable changes in eating behavior , clinical ly significant weight loss and reduction in blood pressure . Treatment with the Tantalus ™ System is therefore a promising minimally invasive treatment for obesity Background Intermittent , reversible intraabdominal vagal blockade ( VBLOC ® Therapy ) demonstrated clinical ly important weight loss in feasibility trials . EMPOWER , a r and omized , double-blind , prospect i ve , controlled trial was conducted in USA and Australia . Methods Five hundred three subjects were enrolled at 15 centers . After informed consent , 294 subjects were implanted with the vagal blocking system and r and omized to the treated ( n = 192 ) or control ( n = 102 ) group . Main outcome measures were percent excess weight loss ( percent EWL ) at 12 months and serious adverse events . Subjects controlled duration of therapy using an external power source ; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission . Devices in both groups performed regular , low-energy safety checks . Data are mean ± SEM . Results Study subjects consisted of 90 % females , body mass index of 41 ± 1 kg/m2 , and age of 46 ± 1 years . Device-related complications occurred in 3 % of subjects . There was no mortality . 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group . Weight loss was related linearly to hours of device use ; treated and controls with ≥12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL , respectively . Conclusions VBLOC ® therapy to treat morbid obesity was safe , but weight loss was not greater in treated compared to controls ; clinical ly important weight loss , however , was related to hours of device use . Post- study analysis suggested that the system electrical safety checks ( low charge delivered via the system for electrical impedance , safety , and diagnostic checks ) may have contributed to weight loss in the control group
AIM To evaluate the current state-of-the-art of gastric electrical stimulation to treat obesity .