(HealthDay News) – For patients with type 2 diabetes, an intensive lifestyle intervention consisting of diet and exercise is not associated with a decrease in cardiovascular events in long-term follow-up, according to a study published online June 24 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Diabetes Association, held from June 21–25 in Chicago.
Rena R. Wing, PhD, from the Warren Alpert Medical School of Brown University and Miriam Hospital in Providence, RI, and colleagues randomized 5,145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention (decreased caloric intake and increased physical activity) or to receive diabetes support and education. Participants were followed for a maximum of 13.5 years.
At a median follow-up of 9.6 years, on the basis of a futility analysis, the researchers stopped the trial early. Throughout the study, weight loss was greater in the intervention group (8.6% vs. 0.7% at one year; 6% vs. 3.5% at study end). In the lifestyle intervention group, greater reductions were seen in glycated hemoglobin and greater initial improvements were seen in fitness and all cardiovascular risk factors, with the exception of low-density lipoprotein cholesterol levels. There was no significant difference between the groups in the primary outcome, a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina (hazard ratio in intervention group, 0.95; P=0.51).
“Our study showed that an intensive lifestyle intervention did not reduce the risk of cardiovascular morbidity or mortality, as compared with a control program of diabetes support and education, among overweight or obese patients with type 2 diabetes,” the authors write.
The study was partially funded by the nutrition industry.