Diabetes Lifestyle Intervention Trial Stopped: Cardiovascular Outcomes Unchanged

A long-term study of intensive lifestyle intervention to reduce cardiovascular risks in overweight people with type 2 diabetes finds no advantage over usual diabetes care. The results appear in the New England Journal of Medicine.

In a multicenter study conducted in the U.S., researchers randomized 5145 people (averaging 59 years of age and a BMI of 36) either to a lifestyle-based intervention that sought to lower calorie intake and increase activity, or to usual care. The primary outcome was a composite of death from cardiovascular causes, MI, stroke, or hospitalization for angina.

The planned maximum follow-up was almost 14 years, but the study was stopped after a median of roughly 10 years, when an interim analysis found no difference in the incidence of the primary outcome (1.83 events per 100 person-years in the intervention group, vs. 1.92 in controls).



NEJM article

NEJM editorial