Look AHEAD Trial Halted

Lifestyle Management Fails to Reduce CV Events in Patients With Diabetes

Disclosures

October 19, 2012

LOS ANGELES, California — The Action for Health Diabetes (Look AHEAD) study, a trial comparing an intensive lifestyle-intervention program aimed at achieving and maintaining weight loss and fitness in patients with type 2 diabetes, has been stopped for futility.

A large cardiovascular-outcomes study funded by the National Institutes of Health that included 5145 adults with diabetes and a body mass index >25 kg/m2, Look AHEAD failed to show a difference in the rate of nonfatal MI, nonfatal stroke, death, or hospitalization for angina among patients randomized to an intensive lifestyle intervention and those randomized to a control arm consisting of education alone.

Despite significant reductions in weight and improvements in physical-fitness levels among patients with diabetes, investigators concluded that the intervention arm, which included individual sessions with a nutritionist and/or personal trainer, as well as group sessions and refresher courses, failed to provide any benefit in terms of cardiovascular outcomes.

Dr Anne Peters (University of Southern California, Los Angeles), one of the study investigators, said in an interviewthat the trial was successful on one level--namely, that patients lost weight and improved their fitness. Data published at four years showed that the intensive intervention led to weight loss of up to 10% in the first year and that patients maintained a 6.5% reduction in body weight in the following three years. Over an 11-year follow-up period, the patients reported a 5% reduction in body weight from baseline, said Peters.

In addition, early data showed that treadmill fitness levels, hemoglobin A1c levels, systolic and diastolic blood pressure, HDL-cholesterol levels, and triglyceride levels were all significantly improved among patients in the lifestyle-intervention arm when compared with the control group. The only cardiovascular risk factor that remained unchanged with treatment was LDL-cholesterol levels.

Despite the lack of cardiovascular benefit observed in Look AHEAD, Peters stressed that diabetic patients should not stop exercising or begin eating anything they wish.

"We do know that weight loss and exercise can prevent diabetes," said Peters. "I am a big advocate of prevention, both early prevention of obesity altogether, as well as prevention of diabetes in individuals who have become overweight. Lifestyle changes can help prevent diabetes. Once you have diabetes, I think weight loss and exercise can have benefits, but they are not going to reduce the risk for the primary outcome that we set for Look AHEAD, which was a risk for macrovascular events or death."

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