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NCT06363747
The Medically Reproducing Bariatric Surgery (MRB) II Study
Phase 2, PHASE3 trial testing Very Low Calorie Diet in Type 2 Diabetes in 50 participants. Participants enrolled and being followed up; not accepting new ones.
3 November 2025
Quick facts
| Lead sponsor | Durham VA Medical Center |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 24 June 2024 |
| Primary completion | 3 November 2025 |
| Estimated completion | 3 November 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Very Low Calorie Diet
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
- Obesity — all drugs for Obesity →
Sponsor
Durham VA Medical Center
Who can join
Adults 25 to 75, any sex, with Type 2 Diabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06363747
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Very Low Calorie Diet
Trials testing the same drug.
- NCT06881485 — Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery · NA · recruiting
- NCT06183034 — Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAF · NA · unknown
- NCT06027567 — The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Co · Phase 4 · completed
- NCT04957589 — VLCD & Adjuvant Exercise Effect in Overweight Diabetic Men · NA · completed
- NCT03132662 — Omega-3 vs Very Low Calorie Diet for Liver Size Reduction · NA · unknown
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Durham VA Medical Center trials
Trials by the same sponsor.
- NCT06452446 — Telehealth-based Symptom Management for Veterans Treated With Selinexor · active not recruiting
- NCT06142006 — The Diabetes Staging System in Patient Aligned Care Teams · recruiting
- NCT04775589 — Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis · NA · active not recruiting
- NCT01898013 — Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans · Phase 2 · completed
- NCT00644423 — Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06363747 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Durham VA Medical Center
- Last refreshed: 7 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06363747.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing