Comparing Bariatric Surgery and Medical Weight Management to Lower Heart Risks in Adults with Severe Obesity and High Cardiovascular Disease Risk

What this Trial Is About

Researchers are evaluating the effects of bariatric surgery compared to medical weight management MWM in patients with severe obesity and high-risk cardiovascular disease CVD. The study aims to determine if bariatric surgery can safely reduce the risk of major cardiovascular events. It also examines the cost-effectiveness of bariatric surgery and includes additional sub-studies on mental health, cognition, cardiac structure and function, and molecular profiling. Participants will be randomly assigned to receive either bariatric surgery or medical weight management. Bariatric surgery options include gastric bypass, sleeve gastrectomy, or duodenal switch, chosen by the surgeon. Medical weight management involves standard care such as dietary, lifestyle, and behavioral counseling, which may include low-calorie diets, meal replacements, or anti-obesity medications based on local practices. Surgery patients may receive a low-fat, high-protein meal replacement before the procedure, and perioperative care follows local guidelines. During the study, participants will be monitored for cardiovascular outcomes over an average of 6 years, with additional mental health and cognition assessments at 3 years. The study tracks events like heart attacks, strokes, hospitalizations, diabetes status, and heart rhythm changes. Researchers will also analyze cost-effectiveness in quality adjusted life years. Safety and health status will be regularly assessed, and participant involvement includes ongoing follow-up visits and evaluations throughout the study period.

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial