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NCT Number: NCT06363747

The Medically Reproducing Bariatric Surgery (MRB) II Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Greenville VA Health Care Center

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

very low calorie diet

Other

Optifast is a medically supervised very low-calorie diet (VLCD) diet that safely induces caloric restriction

Other names: Optifast

Primary outcomes

  1. Glycemic Control

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

    Hemoglobin A1C

Secondary outcomes

  1. Weight lost

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

    Percentage of weight loss

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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