STAMPEDE: An Update for GIs About Bariatric Surgery for Type 2 Diabetes

By Ibrahim Hanouneh, MD

Type 2 diabetes impacts almost every organ system in the body, including the gastrointestinal (GI) system. Obesity and diabetes increase patients’ risks for developing nonalcoholic fatty liver disease, gastroparesis, esophageal dysmotility, gastroesophageal reflux disease and glycogenic hepatopathy.

But now, data from an ongoing study by a group of researchers at Cleveland Clinic offer new hope for obese patients with type 2 diabetes — which may also help resolve many of these common GI complications. The study, known as STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently), indicates that bariatric surgery is a highly effective and durable treatment for type 2 diabetes in obese patients.

What STAMPEDE examined

The trial was headed by lead investigator Philip Schauer, MD, Director of Cleveland Clinic’s Bariatric and Metabolic Institute, located within our Digestive Disease Institute. It involved 150 patients (ages 20 to 60 years) with type 2 diabetes and with a body mass index of 27 to 43.

The study compared glycemic control with advanced medical therapy versus medical therapy plus one of two types of bariatric surgery (Roux-en-Y or sleeve gastrectomy). Nearly all surgical patients were able to discontinue insulin and other diabetic medications within three years after surgery. Additionally, there was a significant reduction in the need for blood pressure and cholesterol medications following bariatric surgery. Patients who underwent bariatric surgery also experienced an improvement in quality of life compared with those receiving medical therapy.

This is the first randomized controlled clinical trial that compares surgery with intensive medical therapy head-to-head for obese patients with type-2 diabetes. The results of the study were presented at the American College of Cardiology’s annual conference in Washington, D.C., and published in the New England Journal of Medicine.

The next major goals of the study, which will continue for at least five years of follow-up, are to determine the effects of bariatric surgery on reduction of microvascular and macrovascular complications. The Cleveland Clinic Coordinating Center for Clinical Research (C5Research) serves as the trial coordinator.

Why this study is of interest to GIs

As gastroenterologists, we will also be keeping our eye on any upcoming data regarding the effect bariatric surgery may have on reversing GI complications of obesity and diabetes. For instance, recent research presented at Digestive Disease Week 2014 shows that bariatric surgery improves liver histology in severely obese patients and is associated with resolution of fatty liver disease in the majority of patients.

These results are exciting, as they suggest bariatric surgery should be considered as a treatment for nonalcoholic steatohepatitis in severely obese patients — and potentially for an even wider patient population with other GI complications of obesity and diabetes in the future.

Dr. Hanouneh’s specialty interests include liver transplantation, alcoholic and nonalcoholic fatty liver disease, and chronic hepatitis C virus infection.