Clinical Research
Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes in Overweight-to-Moderately Obese Patients: A Randomized Clinical Trial
The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass plus optimal medical therapy versus Intensive lifestyle modification plus optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34 kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of Asian descent; HbA1c: 7-10%). The primary outcome will be optimal glycemic control (HbA1c<6.5) after 2 and 5 years.
This is a single center, prospective randomized study intended to be a pilot investigation whose results can inform clinicians and researchers for future larger or multi-site trials of diabetes surgery. This study will also be used for the definition of a "core" protocol for independent randomized clinical trials to be carried out at various centers participating in a multinational consortium.
Comparison of caloric restriction and Roux-en-Y-Gastric Bypass on glucose homeostasis
Our study hopes to clarify if the early improvement/resolution of type 2 diabetes after weight loss surgery is due to reduced food intake or to surgery itself. We will compare the early effects on glucose levels in obese diabetic subjects (BMI: 35-55 kg/m2, HbA1c: 7-10%) treated with 5 days of caloric restriction before surgery versus that of subjects who are immediately postoperative Roux-en-Y gastric bypass. A third group of obese diabetic subjects (BMI: 35-55 kg/m2, HbA1c: 7-10%) will undergo laparoscopic gastric banding (Lap-Band) or sleeve gastrectomy and be followed in regard to their glucose control to compare the confounding factors of the gastric bypass group.
Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI)<35
The aim of this study is to evaluate the metabolic effects of laparoscopic Roux-en-Y-Gastric Bypass in controlling type 2 diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (< 7%).
