Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.

Inclusion Criteria:

• Type 2 diabetes mellitus with HbA1c > 7.0%
• Body mass index > 27 and < 43 kg/m2
• Candidate for general anesthesia

Exclusion Criteria:

• Prior bariatric surgery of any kind
• Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
• Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
• Known history of chronic liver disease (except for NAFLD/NASH)
• Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
• Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
• Severe pulmonary disease defined as FEV1 < 50% of predicted value
• Pregnancy