The Medically Reproducing Bariatric Surgery (MRB) II Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363747
• Other study ID #: 123456
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 3, 2024
• Est. completion date: June 3, 2025

Study information

• Verified date: April 2024
• Source: Durham VA Medical Center
• Contact: Sandra Garcia Juarez, BS
• Phone: 2528302149
• Email: sandra.garciajuarez[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 3, 2025
• Est. primary completion date: June 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Other:
• Very Low Calorie Diet
Optifast is a medically supervised very low-calorie diet (VLCD) diet that safely induces caloric restriction

Locations

Country	Name	City	State
United States	Greenville VA Health Care Center	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Durham VA Medical Center	Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptom Item Checklist	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
Primary	Glycemic Control	Hemoglobin A1C	baseline, week 12, week 24, week 48
Secondary	Weight lost	Percentage of weight loss	baseline, week 12, week 24, week 48
Secondary	Medication Intensity	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
Secondary	Health Related Quality of Life	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

External Links

•   SCL-90-R Questionnaire