期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 369, 期 2, 页码 145-154出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1212914
关键词
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资金
- National Institutes of Health (NIH)
- Department of Health and Human Services agencies
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [DK57136, DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135, DK56992]
- Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases
- National Heart, Lung, and Blood Institute
- National Institute of Nursing Research
- National Center on Minority Health and Health Disparities
- NIH Office of Research on Women's Health
- Centers for Disease Control and Prevention
- Johns Hopkins Medical Institutions Bayview General Clinical Research Center [M01RR02719]
- Massachusetts General Hospital Mallinckrodt General Clinical Research Center
- Massachusetts Institute of Technology General Clinical Research Center [M01RR01066]
- University of Colorado Health Sciences Center General Clinical Research Center [M01RR00051]
- Clinical Nutrition Research Unit [P30 DK48520]
- University of Tennessee at Memphis General Clinical Research Center [M01RR0021140]
- University of Pittsburgh General Clinical Research Center [M01RR000056]
- Clinical Translational Research Center
- Clinical and Translational Science Award [UL1 RR 024153]
- NIH [DK 046204]
- VA Puget Sound Health Care System Medical Research Service, Department of Veterans Affairs
- Frederic C. Bartter General Clinical Research Center [M01RR01346]
- FedEx
- Health Management Resources
- Johnson Johnson
- Nestle HealthCare Nutrition
- Hoffmann-La Roche
- Abbott Nutrition
- Unilever North America
Background 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. Methods 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. Results 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). Conclusions 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.
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