Call for Analysis of Look AHEAD Data

Abstract

TO THE EDITOR The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial comparing an intensive lifestyle intervention with diabetes support and education in individuals with overweight or obesity and type 2 diabetes to track the development of cardiovascular disease over time. With this letter, the investigators are soliciting interest in the analysis of existing data and biological samples. The trial resulted in a differential effect on weight loss and fitness between the two groups; however, there was no effect on cardiovascular outcomes. As a result, the intervention was stopped after 9.6 years for futility. Nevertheless, there were many health benefits of intensive lifestyle intervention, including improved glucose and lipid control, less sleep apnea, lower liver fat, less depression, improved insulin sensitivity, less urinary incontinence, less kidney disease, reduced need of diabetes medications, maintenance of physical mobility, improved quality of life, and lower costs. It also reduced the risk of very high-risk chronic kidney disease and nephropathy. Look AHEAD was converted to an observational study following the cessation of the intervention with ongoing follow-up of study participants. In order to fulfill data sharing expectations, Look AHEAD data has been submitted to the NIDDK Central Repository (https://repository.niddk.nih.gov/home/) and is available by request. The investigators maintain an extensive repository of biological samples including plasma, serum, urine, and DNA. We, the investigators of Look AHEAD, would welcome the exploration of the data and the samples by interested investigators. Information about how to obtain data or samples for analysis can be found on the Look AHEAD webpage at www.lookaheadtrial.org.