Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type2 Diabetes

Type 2 diabetes (T2D) and obesity are now an endemic worldwide, causing significant morbidity related to renal and cardiovascular diseases, and are the driving force behind preventable mortality. Recent national surveys show that 29.1 million Americans, or 9.3% of the adult population, have diabetes and 34% are obese, which together contribute to substantial individual health burden and societal healthcare costs.

Worldwide Map of Projected Incidence of Obesity

The *Alliance of Randomized Trials of Medicine versus Metabolic Surgery in Type 2 Diabetes* (ARMMS-T2D) consortium originated from four NIH funded randomized control trials at Cleveland Clinic, Joslin Diabetes Center/Brigham and Women’s Hospital (BWH), University of Pittsburgh, and the University of Washington, respectively. These trials evaluated the feasibility and efficacy of bariatric/metabolic surgery compared to multidisciplinary medical and lifestyle management of T2D and body weight with a relatively short follow-up of 1-3 years. Results showed significantly greater diabetes remission in the surgery compared to medical therapy groups. However, they were not of sufficient duration to provide long-term data to assess durability, and hence the data that would support recommendations for the use of bariatric/metabolic surgery to treat lower-BMI patients with T2D.

Funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in July 2017, ARMMS-T2D will combine the four studies, where 355 patients were originally randomized, and 302 patients are currently available for long term follow-up. This rare and valuable cohort provides a unique, timely, and cost-effective opportunity to obtain essential data on the durability of bariatric surgery effects and changes-over-time pertaining to diabetes and related conditions. Specific aims include:

1. To compare the durability of glycemic control, assessed by HbA1c, between patients randomized to bariatric/metabolic surgery or comprehensive medical/lifestyle therapy. 2. To assess the longer-term efficacy and safety outcomes in patients randomized to bariatric/metabolic surgery or comprehensive medical/lifestyle therapy. 3. To identify clinical predictors of diabetes remission and relapse.