Abstract
The Look Action for Health in Diabetes AHEAD Study was designed as a long-term randomized controlled clinical trial and powered to detect differences in cardiovascular outcomes, the primary cause of early morbidity and mortality in type 2 diabetes, among subjects randomized to receive an intensive lifestyle intervention or a control group of diabetes support and education. The study was terminated early due to the absence of any difference in the primary outcome, defined as a composite of the first postrandomization occurrence of fatal and nonfatal myocardial infarction and stroke, or angina requiring hospitalization. However, important secondary favorable outcomes were observed in those receiving the intensive lifestyle intervention. This included more weight loss, greater fitness, less disability, less depression, reductions in sleep apnea and urinary incontinence, better glycemic control, and more subjects experiencing diabetes remission. These results underscore the importance of lifestyle interventions as a component of diabetes therapy. Long-term follow-up of Look AHEAD participants is planned, despite discontinuation of the intensive lifestyle program.