- Question
- Does an intensive lifestyle intervention aimed at weight loss reduce cardiovascular morbidity and mortality in overweight or obese adults with type 2 diabetes?
- Design
- Randomized, open-label (unmasked) trial of 5145 patients at 16 centers in the United States. It was stopped early for futility at a median follow-up of 9.6 years (maximum 13.5 years).
- Population
- Overweight or obese adults with type 2 diabetes.
- Intervention
- Intensive lifestyle intervention promoting weight loss through reduced caloric intake and increased physical activity, delivered in individual and group sessions.
- Control
- Diabetes support and education, consisting of group sessions on diabetes management and social support.
- Primary outcome
- Composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina.
- Results
- The primary outcome occurred in 403 patients in the intervention group and 418 in the control group (1.83 and 1.92 events per 100 person-years; HR 0.95; 95% CI 0.83 to 1.09; P=0.51). Weight loss was greater with the intervention (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end).
- Conclusion
- An intensive lifestyle intervention focused on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes.
- Why it matters
- It showed that weight loss through intensive lifestyle change, despite improvements in glycemic control and several risk factors, did not translate into fewer cardiovascular events in this population, tempering expectations for this approach as a cardiovascular prevention strategy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026