The Medically Reproducing Bariatric Surgery (MRB) II Study (NCT06363747)
The Medically Reproducing Bariatric Surgery (MRB) II Study: SEMAGLUTIDE Followed by OPTIFAST in Veterans With Type 2 Diabetes
๐ฉบ Plain-English Summary (8th-Grade Level)
Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB. The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB.
Who can join: Review the eligibility criteria below.
Location: Greenville VA Health Care Center โ Greenville, North Carolina
Age range: 25 Years to 75 Years
๐งช Interventions in This Study
- Very Low Calorie Diet (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Greenville VA Health Care Center โ Greenville, North Carolina
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 2 Diabetes
- Continuous Glucose Monitoring System Feasibility in Youth With T2D โ San Francisco, California
- Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D โ Oklahoma City, Oklahoma
- Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus โ Minneapolis, Minnesota
- Diabetes Medical Nutrition Therapy in Southeastern African American Women โ Nashville, Tennessee
- E3 Diabetes - Closing the Gap in Diabetes Control โ Chicago, Illinois
- Recreational Basketball to Increase Participation in Diabetes Prevention โ Atlanta, Georgia
Explore by condition: All Type 2 Diabetes clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.