Trial Summary
What is the purpose of this trial?This trial compares weight loss from surgery and dieting in obese people, some with diabetes. Both methods aim to improve how the body processes sugar and overall health by significantly reducing body weight.
Eligibility Criteria
This trial is for obese individuals with or without Type 2 Diabetes, having a BMI between 34-55 kg/m². They must not use tobacco, be pregnant/breastfeeding, have had previous intestinal surgery, significant organ dysfunction (other than diabetes), or take meds affecting metabolism. Exercise should be less than 90 minutes per week.Inclusion Criteria
I have Type 2 Diabetes.
I have a BMI between 34-55, may or may not have Type 2 Diabetes, and agree to participate.
I am scheduled for weight loss surgery.
Treatment Details
The study compares the effects of Roux-en-Y Gastric bypass (RYGB) surgery and a low-calorie diet on weight loss and metabolic health in obese patients. It looks at how each method affects insulin sensitivity in the liver and muscles, beta-cell function, and overall metabolic balance over a day.
2Treatment groups
Experimental Treatment
Active Control
Group I: Roux-en-Y gastric bypass (RYGB)Experimental Treatment1 Intervention
Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss.
Group II: Low-calorie dietActive Control1 Intervention
Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator