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Trial · Interventional

Active, not recruitingPhase 2/3Registry data

The Medically Reproducing Bariatric Surgery (MRB) II Study

NCTNCT06363747 (opens ClinicalTrials.gov in a new tab)Other id123456
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Semaglutide, does not test it. It appears in the title.

Overview

Status
Active, not recruiting
Phase
Phase 2/3
Enrollment
50 participants (estimated)
Sponsor
Durham VA Medical Center · Fed
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
24 Jun 2024
Primary completion
3 Nov 2025 (estimated)
Completion
3 Nov 2025 (estimated)
First posted
12 Apr 2024
Last update posted
7 Feb 2025
Conditions
Type 2 Diabetes · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 2/3

    The Medically Reproducing Bariatric Surgery (MRB) II Study

    NCT06363747

    24 Jun 2024 to est. 3 Nov 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Very Low Calorie DietOther

Arms2

  • No intervention

    Standard of Care

    Patients in the control group will attend four in-person visits with the study coordinator at baseline, week 12, week 24, and week 48 to measure study outcomes. Patients will get medical drug management (endocrinologist), nutritional/behavioral counseling (dietician, psychologist) and will be maintained on once weekly GLP-1 agonist +/- other diabetic medicines.

  • Experimental

    Very Low Calorie Diet

    Patients in the experimental group will attend 4 in-person visits with the study coordinator at baseline, week 12, week 24, and week 48 to measure study outcomes. Additionally, they will undergo a 2 week run-in phase before baseline with weekly meetings to ensure that they are able to tolerate and comply with Optifast. Patients will get medical drug management (endocrinologist), nutritional/behavioral counseling (dietician, psychologist) and will be maintained on Optifast + once weekly GLP-1 agonist +/- other diabetic medicines.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glycemic Control

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

    Registry description

    Hemoglobin A1C

Secondary outcomes(3)

  1. Weight lost

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

    Registry description

    Percentage of weight loss

  2. Medication Intensity

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

    Registry description

    Medication Effect Score (MES) measures the intensity of antiglycemic medicines used to treat type 2 diabetes with higher scores indicating greater medication intensity.

  3. Health Related Quality of Life

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

    Registry description

    Problem Areas In Diabetes (PAID) is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. A score of 40 or above is indicative of severe emotional distress.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2018

11 results

Semaglutide for type 2 diabetes mellitus: A systematic review and meta-analysis.

Andreadis et al. 2018Diabetes, obesity & metabolismcited by 110

PMID 29756388DOI 10.1111/dom.13361PUB-29756388

Full text at the publisher11 results
Publisher pageSee results (11)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 25 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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