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ARS Home » Plains Area » Houston, Texas » Children's Nutrition Research Center » Research » Publications at this Location » Publication #298301
Title: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

Author
item FOREYT, JOHN - Children'S Nutrition Research Center (CNRC)

Submitted to: New England Journal of Medicine
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 2/1/2013
Publication Date: 6/24/2013
Citation: The Look AHEAD Research Group. 2013. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. New England Journal of Medicine. 369:145-154.

Interpretive Summary: The rates of overweight and obese individuals have grown at an alarming rate globally. For patients with type 2 diabetes (T2D), weight loss has been recommended as an effective course of treatment. However these recommendations come from the basis of short-term studies, as long-term studies and the effects of weight loss on cardiovascular disease in patients with T2D remains unknown. In this study, we examined whether an intensive lifestyle intervention for weight loss would decrease the rates of cardiovascular disease and death among patients with T2D. The study was conducted at 16 different centers in the United States. A total of 5145 overweight or obese patients with T2D were randomly assigned to either an intensive lifestyle intervention (ILI) group that promoted weight loss through decreased caloric intake and increased physical activity or a traditional diabetes support and education (DSE) program. The main purpose of the study was to determine the combined effects of deaths from cardiovascular diseases, nonfatal heart attacks, nonfatal strokes, or hospitalization for chest pains during the study period of 13.5 years. The study was stopped early after 9.6 years due to a lack of results and supporting data for the study's initial purpose. Weight loss was greater in the ILI group than the DSE group. However, the primary outcome, that the ILI group would lower the rates of cardiovascular disease and death in T2D patients, was unsupported, with 403 ILI patients and 418 DSE patients experiencing a cardiovascular event during the study period. We found that an ILI focusing on weight loss did not reduce the rate of cardiovascular disease and death in overweight or obese adults with T2D. Further research is needed to determine an effective treatment for overweight and obese patients with T2D to reduce the rates and deaths from cardiovascular disease.

Technical Abstract: Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes.