The growing incidence of obesity and type 2 diabetes mellitus globally is widely recognized as one of the most challenging contemporary threats to public health.1 Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. The current goal of medical treatment is to halt disease progression by reducing hyperglycemia, hypertension, dyslipidemia, and other cardiovascular risk factors.2,3 Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control.4 Observational studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and cardiovascular risk factors in severely obese patients with type 2 diabetes.5-9 Few randomized, controlled trials have compared bariatric surgery with intensive medical therapy, particularly in moderately obese patients (defined as those having a body-mass index [BMI, the weight in kilograms divided by the square of the height in meters] of 30 to 35) with type 2 diabetes.10 Accordingly, many unanswered questions remain regarding the relative efficacy of bariatric surgery in patients with uncontrolled diabetes.
This randomized, controlled, single-center study, called the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial, was designed to compare intensive medical therapy with surgical treatment (gastric bypass or sleeve gastrectomy) as a means of improving glycemic control in obese patients with type 2 diabetes.