Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes

Study Questions:

What is the impact of an intensive lifestyle intervention for weight loss on cardiovascular morbidity and mortality in patients with type 2 diabetes?


The investigators randomly assigned 5,145 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, 0.83-1.09; p = 0.51).


The authors concluded that 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.


This study reported that at a median follow-up of almost 10 years, there was no significant difference in cardiovascular morbidity and mortality between intensive lifestyle intervention and a control regimen of diabetes support and education. However, patients in the intervention group had clinically meaningful improvements in glycated hemoglobin levels, they were more likely to have a partial remission of diabetes during the first 4 years of the trial than were those in the control group, and had reductions in urinary incontinence, sleep apnea, depression, and improvements in quality of life, physical functioning, and mobility. Although there was no clear evidence of cardiovascular benefit in this study, the investigators have shown that physical activity and diet can safely reduce the burden of diabetes and have reaffirmed the importance of lifestyle modification as a critical component of contemporary diabetes care.

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Lipid Metabolism, Nonstatins, Diet, Sleep Apnea

Keywords: Depression, Myocardial Infarction, Stroke, Life Style, Weight Loss, Overweight, Diabetes Mellitus, Type 2, Cost of Illness, Sleep Apnea Syndromes, Hemoglobin A, Glycosylated, Cholesterol, Quality of Life, Motor Activity, Urinary Incontinence, Obesity, Energy Intake, Diet, Hospitalization

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