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Losing weight -- an average of 5% of total body weight -- 'and keeping it off for 4 years didn't reduce the number of heart attacks or strokes in persons with diabetes. 
  
 That result prompted the National Heart, Lung, and Blood Institute to pull the plug on its massive Look AHEAD (Action for Health in Diabetes) study. 
  
 The study enrolled 5,145 people with type 2 diabetes and a BMI greater than 25, randomizing half to a lifestyle intervention and half to a general program of diabetes support and education. 
  
 Although those in the intervention group kept off 5% of their initial body weight at 4 years, there was no difference between them and the standard care group in the rate of myocardial infarction, stroke, hospitalizations for angina, and cardiovascular death -- the primary outcome. 
  
 Essentially, there was no harm from the intervention, but there was no benefit either, according to a statement from the NIH. 
  
 Because of the finding of futility, the study's data and safety monitoring board recommended the trial be stopped. 
  
 Mary Evans, MD, director of special projects in nutrition, obesity, and digestive diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, told MedPage Today that people who "volunteer for a weight-loss intervention study involving reductions in calorie intake and increased physical activity may be healthier than the general population with type 2 diabetes." 
  
 She said that participants had to pass a treadmill test to assure it was safe for them to exercise. They also received annual feedback about their risk factors, including HbA1c, blood pressure, and cholesterol levels. 
  
 After the first year, Look AHEAD participants in the lifestyle intervention arm had lost 10% of their initial body weight, but as time went on, they gained some of it back. The standard care group lost about 1% of its initial body weight at both 1 and 4 years. 
  
 Despite no reduction in cardiovascular events in those in the intense intervention arm, they did experience other health benefits. Patients in this group saw improvements in sleep apnea and mobility, as well as quality of life. In addition, their diabetes medications were reduced. 
  
 In addition, at 1 and 4 years, both diabetes control (glucose, HbA1c) and most cardiovascular disease risk factors (blood pressure, HDL cholesterol, triglycerides) were more favorable in the lifestyle intervention than in the control group with the exception of LDL cholesterol, which was not different between groups at year 1, Evans shared. 
  
 At year 4, those in the intensive lifestyle intervention group continued to have more favorable diabetes control and CVD risk factor reduction, with the exception of LDL-C in which there were slightly greater reductions in the standard care group. Participants in the lifestyle intervention group maintained greater improvements in fitness at both years 1 and 4, Evans said. 
  
 To be enrolled, patients had to have their blood pressure under at least moderate control (160/100 mmHg), HbA1c levels ≤11%, and fasting triglycerides concentration less than 600 mg/dL. The trial included those with and without a history of cardiovascular disease. 
  
 "Cardiovascular event rates in diabetic individuals with heart disease are expected to be approximately twice those of diabetic individuals without a history of heart disease," according to the study protocol. 
  
 The ages of participants ranged from 45 to 76, and 60% were women. 
  
 "Data from the end of the study are currently being analyzed to better understand the relationship between changes in fitness, weight, diabetes control, cardiovascular disease risk factor control, and outcomes in the Look AHEAD study," Evans said. 
  
 Researchers also are exploring differences in subgroups, such as minorities (about 37% of the total population) and those with a history of cardiovascular disease. 
  
 From The American Heart Association: ||||| Losing a small amount of weight doesn’t appear to lower the risk of heart attacks and strokes in people with diabetes who are already getting good medical care, according to a long and expensive clinical experiment whose results were announced Friday. 
  
 While modest weight loss has benefits in how overweight diabetics feel, sleep and move, whatever benefit it may confer in preventing cardiovascular disease — which is what most diabetics die from — is too small to measure, the study found. 
  
 “We were hoping that a weight-loss program would help reduce cardiovascular disease, but now we have the answer that it doesn’t,” said Mary E. Evans, a physician at the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, which paid for the study. 
  
 The results will probably surprise many physicians and patients but are not likely to change the advice they give and get. 
  
 “We feel that there are many reasons why people with Type 2 diabetes should control their weight,” said Rena R. Wing, the researcher at Brown University’s Miriam Hospital in Providence, R.I., who headed the experiment. But she added: “I think the patients in the intensive weight-loss group are very disappointed. They’d worked hard to make these changes.” 
  
 The study, which began in 2001, was scheduled to last two more years. In mid-September, however, an independent monitoring board advised NIH that it be stopped in its current form because the weight-loss “intervention” wasn’t having its hoped-for effect. 
  
 The Look AHEAD (Action for Health in Diabetes) trial involved hundreds of doctors, nurses, dieticians and exercise therapists at 16 medical centers. It cost about $20 million a year, or about $220 million over its 11-year-life. 
  
 The researchers recruited 5,145 people with Type 2 diabetes, which is the form that generally comes on in adulthood and is strongly associated with being overweight. Type 1 diabetes, an auto-immune disease, is the opposite. It comes on in childhood, and its sufferers are usually thin. 
  
 About 60 percent of the volunteers were women and slightly more than one-third were minorities. The average age was 58. 
  
 Half of the people were randomly assigned to get intensive dietary counseling on how to limit their calories. They were provided meal substitutes such as Slimfast drink. They were also urged to exercise more and instructed how to do so safely. They met weekly in support groups and once a month with a counselor, although that amount of attention was eventually reduced to a monthly visit and a monthly phone call. 
  
 The other half of the participants got less intensive diet and exercise advice, at first four times a year and later just once a year. Everyone was treated by her or his own doctor, who got an annual summary of the patient’s progress. 
  
 In the first year, the people with the intensive counseling lost 8 percent of their weight. They gained some back, but over the decade of the study maintained an average 5 percent reduction from their starting weight — about 10 pounds. The people in the less-intensive “arm” of the study lost, on average, about 1 percent of their body weight. 
  
 By the end of 11 years, there was no difference between the two groups in the rate of heart attack or stroke. 
  
 The study illustrates the difficulty of doing research on how to treat a disease at a time when treatment is changing rapidly. 
  
 There is currently a big push to have diabetics lower their cardiovascular “risk factors” even if they have no evidence of heart disease. Many physicians urge much lower blood pressure and cholesterol goals than was common a decade ago. That more aggressive treatment appears to be having an effect. 
  
 Nationwide, death rates from heart attack and stroke in diabetics fell 40 percent between 1997 and 2006. The difference between diabetics and non-diabetics in the risk of dying of cardiovascular disease was cut by more than half. This was a period during which obesity rates rose for both diabetics and non-diabetics. Overall, this trend was evidence that, for whatever reason, diabetes was less deadly than it used to be. 
  
 The downward trend in heart attack and stroke was experienced by the people in the Look AHEAD study,too. The entire group suffered only half the heart attacks and strokes that the researchers had predicted when they designed the study. Four years into the study, the group getting the less-intense counseling actually had a slightly more favorable cholesterol profile than those in the intensive weight-loss group. 
  
 How the risk profile of the two groups changed over the last seven years of the study isn’t known at this point. The information exists and will be analyzed over the next few months. 
  
 It may turn out that because of changing norms of medical practice, along with the attention of being in the study, the people in Look AHEAD reduced their risk so much that the benefit of modest weight loss — if it exists — was too small to see. ||||| About 25 million Americans have Type 2 diabetes. Many are overweight or obese. On average, the disease increases heart disease risk by 2 to 2 ½ times, said Dr. Ronald Kahn, chief academic officer at the Joslin Diabetes Center in Boston. 
  
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 It seemed logical that diet and exercise would help reduce that risk. An earlier federal study found that an intense diet and exercise program helped prevent overweight or obese people with elevated blood sugar levels from crossing the line into diabetes. The hope was that a similar program could also protect people from heart disease. 
  
 The study randomly assigned 5,145 overweight or obese people with Type 2 diabetes to either a rigorous diet and exercise regimen or to sessions in which they got general health information. The diet involved 1,200 to 1,500 calories a day for those weighing less than 250 pounds and 1,500 to 1,800 calories a day for those weighing more. The exercise program was at least 175 minutes a week of moderate exercise. 
  
 But 11 years after the study began, researchers concluded it was futile to continue — the two groups had nearly identical rates of heart attacks, strokes and cardiovascular deaths. 
  
 The investigators are analyzing their data and will be publishing them in research papers. 
  
 But the outcome is clear, said Dr. David Nathan, a principal investigator and director of the Diabetes Center at Massachusetts General Hospital. “We have to have an adult conversation about this,” he said. “This was a negative result.” 
  
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 The study participants assigned to the intensive exercise and diet program did lose about 5 percent of their weight and managed to keep it off during the study. That was enough to reduce cardiovascular risk factors. 
  
 “We showed that meaningful weight loss — let’s put ‘meaningful’ in quotes — could be established and maintained,” Dr. Nathan said. “To me that means we did a good experiment. We had a fair test of this hypothesis.” 
  
 Some, like Dr. John Buse, director of the University of North Carolina’s diabetes center, said the study confirmed what they would have expected. Dr. Buse, a former president of the American Diabetes Association, said treatments including smoking cessation, statins to reduce cholesterol and blood pressure medications are so powerful that they could swamp the modest effects of weight loss or exercise on cardiovascular risk. 
  
 Other medical experts said they were waiting for release of the detailed data collected by the researchers before interpreting the study. 
  
 “It is hard to tell anything without the details of the study,” said Dr. Irl Hirsch, medical director of the Diabetes Care Center at the University of Washington. 
  
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 Dr. Nathan, though, said the results meant that people with diabetes might have a choice. The group assigned to diet and exercise ended up with about the same levels of cholesterol, blood pressure and blood sugar as those in the control group, but the dieters used fewer medications. 
  
 “That may be the choice we are highlighting,” Dr. Nathan said. “You can take more medications — and more, I should say, expensive medications — or you can chose a lifestyle intervention and use fewer drugs and come to the same cardiovascular disease risk.” 
  
 He is not going to say which is better, Dr. Nathan added. That is up to the individual. But, he said, “those are real choices.” |||||
Output:
Many people with type 2 diabetes are overweight, and most diabetics die from heart disease. So it would follow that if diabetics followed a healthier diet and lost weight, they'd reduce their risk of a heart attack or stroke, right? Turns out, no. A massive long-range study has concluded that the lifestyle change makes no difference in terms of heart disease for people with type 2, reports MedPageToday. In fact, researchers stopped the study of 5,145 people two years early—it started in 2001—because the results were so clear. “I was surprised,” the study chairwoman tells the New York Times. But "you do a study because you don’t know the answer.” Researchers emphasize that it still makes sense for diabetics to shed weight for a host of other health reasons, which means that doctors' advice probably won't change much, notes the Washington Post. It's just that diabetics' risk of heart disease won't change much, either, maybe because any medication they're taking trumps the effects of diet and exercise. "I think the patients in the intensive weight-loss group are very disappointed," adds the researcher. "They’d worked hard to make these changes.”