The Medically Reproducing Bariatric Surgery (MRB) II Study

February 5, 2025 updated by: Durham VA Medical Center

The Medically Reproducing Bariatric Surgery (MRB) II Study: SEMAGLUTIDE Followed by OPTIFAST in Veterans With Type 2 Diabetes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

MRB II is a two arm 50-week study that will recruit Veteran DM2 patients already on a stable dose of a GLP-1 agonist +/- DM2 agents. The investigators will recruit 50 patients and assign 25 subjects to the control arm and 25 subjects to the experimental arm. The control and experimental arm (n=25) will have in-person visits with the study PI, certified diabetes educator (CDE) and behavioral psychologist (Psych) at baseline, week 12, week 24 and week 48 to optimize glycemic control. Visits with the PI will be one-on-one but visits with CDE/Psych will be shared-medical appointments. Furthermore, the experimental arm (n=25) will also be enrolled in the Optifast medical weight loss program starting with a 2-week run-in phase to determine if they are able to tolerate Isocaloric Optifast (7 meal replacements/day) while also minimizing significant weight loss prior to the start of the study. The patients in the experimental arm successfully completing the run-in phase will then continue and enter the 50-week study.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Greenville VA Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Very Low Calorie Diet
Optifast is a medically supervised very low-calorie diet (VLCD) diet that safely induces caloric restriction
Other Names:
  • Optifast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Control
Time Frame: baseline, week 12, week 24, week 48
Hemoglobin A1C
baseline, week 12, week 24, week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight lost
Time Frame: baseline, week 12, week 24, week 48
Percentage of weight loss
baseline, week 12, week 24, week 48
Medication Intensity
Time Frame: baseline, week 12, week 24, week 48
Medication Effect Score (MES) measures the intensity of antiglycemic medicines used to treat type 2 diabetes with higher scores indicating greater medication intensity.
baseline, week 12, week 24, week 48
Health Related Quality of Life
Time Frame: baseline, week 12, week 24, week 48
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.
baseline, week 12, week 24, week 48

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Item Checklist
Time Frame: 2 week run-in phase
SCL-90-R is a self-report instrument containing 90 items and designed to measure nine current psychiatric symptoms, as well as psychological distress. The SCL-90-R sub-scales assess followings psychiatric symptoms: Somatization, Obsessive Compulsive Disorder, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Each item has five following response categories: 0 = Not at all, 1= little, 2 = some, 3 = very, 4 = severe.
2 week run-in phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durham VA Medical Center

Collaborators

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Moahad Dar, MD, Department of Veteran Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

November 3, 2025

Study Completion (Estimated)

November 3, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456 (Innovate UK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data and/or specimens will be transported BETWEEN sites that are under the auspices of the Durham VA Medical Center. The Greenville VA Health Care Center is the primary study site. Data analysis will be conducted by HSRD located at the Durham VA medical center. Data and/or specimens will be transported to non-VA/VHA sites (e.g., academic affiliates, laboratories, etc.) as coded data which will be shared via email using Azure RMS encryption. The study will use a VA issued laptop. Direct identifiers will be maintained separately from data and or specimens by using a code to "identify" subjects. In a separate database (i.e., a "linking" or "cross-walk" database) this code will be linked to identifying subject information. Reporting of results, such as in scientific papers and presentations, will never identify individual subjects. Data will be presented in aggregate and individual-level data will not be published. No future use of data is currently planned.

IPD Sharing Time Frame

Study protocol was shared with study sponsor prior to IRB submission. Study sponsor will receive a summary of study results at study conclusion but will not have access to individually identifiable information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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