Active not recruitingPhase 2, PHASE3

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

Lead sponsor

Durham VA Medical Center

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥27•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06363747

Org study ID123456

Timeline

Milestones

Study first posted2024-04-12actual

Study start2024-06-24actual

Last update posted2025-02-07actual

Primary completion2025-11-03estimated

Study completion2025-11-03estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age25 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•age >75,

•A1C <7%

•pregnant

•breast feeding

•prior history of pancreatitis

•prior history of gastroparesis

•history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer (contraindication to Liraglutide)

•history of gallstones

•history of hyperoxaluria or calcium oxalate nephrolithiasis

•history of Roux-en-Y gastric bypass or gastric sleeve or any other bariatric procedure,

•type 1 diabetes

•any abnormality on the screening EKG that could subject patient to increased risk during the study

•any gastrointestinal condition causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue)

•unwilling or unable to complete scheduled testing

•any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study

•organ transplantation or those on immunosuppressants

•chronic anticoagulation

•recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months

•chronic prednisone use

•hepatitis

•cirrhosis

•GFR <50

•deep vein thrombosis in past 6 months

•active malignancy

•unstable psychiatric condition including active or current suicidal ideation

•enrolled in another research study related to diet and/or physical activity

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Weight lost

Time frame:baseline, week 12, week 24, week 48

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Glycemic Control

Time frame:baseline, week 12, week 24, week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Medication Intensity

Time frame:baseline, week 12, week 24, week 48

descriptive, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Health Related Quality of Life

Time frame:baseline, week 12, week 24, week 48

change from baseline, improvement

Other/protocol endpoint

Symptom Item Checklist

Time frame:2 week run-in phase

descriptive

Publications (28)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Can We Benefit from the Preoperative Psychometric Test with Symptom Checklist-90-Revised (SCL-90-R) to Predict Weight Loss After Sleeve Gastrectomy?
Obesity surgery2022 May (month)PMID35146601doi:10.1007/s11695-022-05951-yvia CT.gov background
Assessing psychopathology in bariatric surgery candidates: discriminant validity of the SCL-90-R and SCL-K-9 in a large sample of patients.
Eating and weight disorders : EWD2021 Oct (month)PMID33226607doi:10.1007/s40519-020-01068-2via CT.gov background
Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study.
Obesity (Silver Spring, Md.)2019 Jan (month)PMID30421863doi:10.1002/oby.22303via CT.gov background
Semaglutide for type 2 diabetes mellitus: A systematic review and meta-analysis.
Diabetes, obesity & metabolism2018 Sep (month)PMID29756388doi:10.1111/dom.13361via CT.gov background
A systematic review of commercial weight loss programmes' effect on glycemic outcomes among overweight and obese adults with and without type 2 diabetes mellitus.
Obesity reviews : an official journal of the International Association for the Study of Obesity2016 Aug (month)PMID27230990doi:10.1111/obr.12423via CT.gov background
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
The New England journal of medicine2016 Jul 28PMID27295427doi:10.1056/NEJMoa1603827via CT.gov background
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Diabetes care2014 Oct (month)PMID25011946doi:10.2337/dc14-0876via CT.gov background
Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes.
Diabetes, obesity & metabolism2014 Jan (month)PMID23911112doi:10.1111/dom.12191via CT.gov background
Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and β-cell Function in type 2 diabetic patients.
Diabetes2013 Sep (month)PMID23610060doi:10.2337/db12-1762via CT.gov background
Rapid improvement in diabetes after gastric bypass surgery: is it the diet or surgery?
Diabetes care2013 Sep (month)PMID23530013doi:10.2337/dc12-2316via CT.gov background
Disordered insulin secretion in the development of insulin resistance and Type 2 diabetes.
Diabetic medicine : a journal of the British Diabetic Association2012 Aug (month)PMID22443306doi:10.1111/j.1464-5491.2012.03655.xvia CT.gov background
GLP-1 response to a mixed meal: what happens 10 years after Roux-en-Y gastric bypass (RYGB)?
Obesity surgery2012 Jul (month)PMID22419108doi:10.1007/s11695-012-0624-1via CT.gov background
Bariatric surgery versus conventional medical therapy for type 2 diabetes.
The New England journal of medicine2012 Apr 26PMID22449317doi:10.1056/NEJMoa1200111via CT.gov background
Obesity, overweight, and their life course trajectories in veterans and non-veterans.
Obesity (Silver Spring, Md.)2012 Feb (month)PMID21293452doi:10.1038/oby.2011.2via CT.gov background
Prevalence and trends in obesity among US adults, 1999-2008.
JAMA2010 Jan 20PMID20071471doi:10.1001/jama.2009.2014via CT.gov background
Internal consistency and validity assessment of SCL-90-R for bariatric surgery candidates.
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery2010 Nov-Dec (year)PMID20627709doi:10.1016/j.soard.2010.02.039via CT.gov background
Trends in medication use among US adults with diabetes mellitus: glycemic control at the expense of controlling cardiovascular risk factors.
Archives of internal medicine2009 Oct 12PMID19822830doi:10.1001/archinternmed.2009.296via CT.gov background
Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes.
Diabetes care2009 Jan (month)PMID18945920doi:10.2337/dc08-9025via CT.gov background
Will all Americans become overweight or obese? estimating the progression and cost of the US obesity epidemic.
Obesity (Silver Spring, Md.)2008 Oct (month)PMID18719634doi:10.1038/oby.2008.351via CT.gov background
Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association.
Circulation2007 Aug 28PMID17671237doi:10.1161/CIRCULATIONAHA.107.185649via CT.gov background
Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients.
Medical care2007 Mar (month)PMID17304084doi:10.1097/01.mlr.0000254515.63841.81via CT.gov background
Impact of self-reported patient characteristics upon assessment of glycemic control in the Veterans Health Administration.
Diabetes care2007 Feb (month)PMID17259489doi:10.2337/dc06-0771via CT.gov background
The evolving diabetes burden in the United States.
Annals of internal medicine2004 Jun 1PMID15172919doi:10.7326/0003-4819-140-11-200406010-00035via CT.gov background
International physical activity questionnaire: 12-country reliability and validity.
Medicine and science in sports and exercise2003 Aug (month)PMID12900694doi:10.1249/01.MSS.0000078924.61453.FBvia CT.gov background
Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study.
BMJ (Clinical research ed.)2000 Aug 12PMID10938048doi:10.1136/bmj.321.7258.405via CT.gov background
The Problem Areas in Diabetes Scale. An evaluation of its clinical utility.
Diabetes care1997 May (month)PMID9135939doi:10.2337/diacare.20.5.760via CT.gov background
An eight-year experience with a very-low-calorie formula diet for control of major obesity.
International journal of obesity1988 (year)PMID3360564via CT.gov background
Glycemic effects of intensive caloric restriction and isocaloric refeeding in noninsulin-dependent diabetes mellitus.
The Journal of clinical endocrinology and metabolism1985 Nov (month)PMID4044780doi:10.1210/jcem-61-5-917via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.