October 22nd, 2012

NIH Trial of Lifestyle Intervention for Type 2 Diabetes Stopped for Futility After 11 Years

The NIH today announced the early termination of a large randomized trial testing a lifestyle intervention approach to weight loss in type 2 diabetics.

More than 5,000 patients with type 2 diabetes were randomized to participate in an intensive lifestyle intervention program or a traditional program of diabetes support and education in Look AHEAD (Action for Health in Diabetes). In September, after 11 years of followup, the trial was stopped by the NIH after the data and safety monitoring board found no significant differences in cardiovascular events — the primary endpoint of the trial — between the two groups. According to the NIH, however, other benefits from the lifestyle intervention have been found in the course of the trial.

The NIH said that patients in the intervention group lost an average of 8% of their body weight in the first year and maintained a weight loss of nearly 5% at 4 years. By contrast, patients in the control group lost about 1% of their body weight at 1 and 4 years.

“Look AHEAD found that people who are obese and have type 2 diabetes can lose weight and maintain their weight loss with a lifestyle intervention,” said Dr. Rena Wing, chair of the study, in an NIH press release. “Although the study found weight loss had many positive health benefits for people with type 2 diabetes, the weight loss did not reduce the number of cardiovascular events.”

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