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NCT06363747 · ClinicalTrials.gov registry record · Phase 2
The Medically Reproducing Bariatric Surgery (MRB) II Study
A Phase 2 study of Obesity and Type 2 Diabetes, sponsored by Durham VA Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06363747 is a Phase 2 study of Obesity and Type 2 Diabetes that is active but no longer recruiting, run by Durham VA Medical Center. The registered enrollment target is 50 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06363747, a Phase 2 study of Obesity and Type 2 Diabetes, is active but no longer recruiting, sponsored by Durham VA Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Very Low Calorie Diet
Study Locations (1)
North Carolina
- Greenville VA Health Care Center - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2025-11-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06363747
The ClinicalTrials.gov registry entry for NCT06363747 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The listed sponsor is Durham VA Medical Center, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Very Low Calorie Diet is the first listed.
NCT06363747 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06363747 about?
NCT06363747 is a clinical study titled "The Medically Reproducing Bariatric Surgery (MRB) II Study". 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 ofte...
What is the current status of trial NCT06363747?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-06-24. Estimated completion is 2025-11-03.
What conditions does trial NCT06363747 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes.
What interventions are being tested in trial NCT06363747?
The interventions under investigation include: Very Low Calorie Diet (OTHER).
Who is sponsoring clinical trial NCT06363747?
This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06363747 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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