NCT06363747Active, not recruitingPhase 2/3
The Medically Reproducing Bariatric Surgery (MRB) II Study
The Medically Reproducing Bariatric Surgery (MRB) II Study: SEMAGLUTIDE Followed by OPTIFAST in Veterans With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 7 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- 24 Jun 2024
- Primary completion date
- 3 Nov 2025
- Lead sponsor
- Durham VA Medical Center
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06363747
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 50
- From 24 Jun 2024 to the primary completion date, 3 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior history of pancreatitis
- prior history of gastroparesis
- organ transplantation or those on immunosuppressants
Other illness
- history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer (contraindication to Liraglutide)
- history of gallstones
- history of Roux-en-Y gastric bypass or gastric sleeve or any other bariatric procedure,
- type 1 diabetes
- any gastrointestinal condition causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue)
- any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study
- recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months
- hepatitis
- deep vein thrombosis in past 6 months
- active malignancy
- unstable psychiatric condition including active or current suicidal ideation
Lab values
- history of hyperoxaluria or calcium oxalate nephrolithiasis
- GFR \<50
Age
- age \>75,
Other
- A1C \<7%
- pregnant
- breast feeding
- any abnormality on the screening EKG that could subject patient to increased risk during the study
- unwilling or unable to complete scheduled testing
- chronic anticoagulation
- chronic prednisone use
- cirrhosis
- enrolled in another research study related to diet and/or physical activity
Who the study is looking for
- male or female
- age 25-75 years
- BMI \>27
- diagnosis of type 2 diabetes
- weight stable for 1 month
- hemoglobin A1C \>7.0%
- on stable dose of once weekly GLP-1 agonist
- on oral or injectable DM2 medicines
- interested in losing weight
- agreeable to regular visits per study protocol
- access to telephone and reliable transportation and has a VAMC provider
- using a Freestyle Libre glucose monitoring device and/or glucometer device
Age in the registry: 25 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Greenville VA Health Care Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.