Bariatric surgery vs. advanced practice medical management in the treatment of type 2 diabetes mellitus: rationale and design of the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently trial (STAMPEDE)

Abstract

Obesity and Type 2 diabetes mellitus (T2DM) are closely interrelated, and are two of the most common chronic, debilitating diseases worldwide. Surgical approaches to weight loss (bariatric surgery) result in marked improvement of T2DM, however randomized trials directly comparing the efficacy of surgical and medical approaches are lacking. The Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial was designed to evaluate the efficacy of two bariatric surgery procedures involving gastric restriction only (laparascopic sleeve gastrectomy) and gastric bypass (Roux-en-Y) to advanced medical therapy in patients with T2DM with modest obesity with BMI of 27-42 kg/m2. This single site, prospective, randomized controlled trial will enroll 150 subjects who will be followed. The primary end point will be the rate of biochemical resolution of T2DM at 1 year as measured by HbA1c < 6%. The safety and adverse event rates will also be compared between the three arms of the study.