AzTrials
AzTrials

Type 2 DiabetesPhase 2/3NCT06363747

The Medically Reproducing Bariatric Surgery (MRB) II Study

A Phase 2/3 study testing Very Low Calorie Diet in people with Type 2 Diabetes and Obesity, run by Durham VA Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
Very Low Calorie Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
24 Jun 2024to 3 Nov 2025
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female
  • age 25-75 years
  • BMI >27
  • diagnosis of type 2 diabetes
  • weight stable for 1 month
  • hemoglobin A1C >7.0%
Show all 12Show fewer
  • 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

Who cannot join

  • age >75,
  • A1C <7%
  • pregnant
  • breast feeding
  • prior history of pancreatitis
  • prior history of gastroparesis
Show all 26Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Greenville VA Health Care Center

    Greenville, North Carolina, 27834

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Very Low Calorie Diet
Keywords
Optifast, Type 2 diabetes, Semglutide
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Very Low Calorie DietOther

    Also called Optifast

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

Study groups in NCT06363747
Study groupRoleWhat they receive
Standard of CareNo interventionPatients 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.
Very Low Calorie DietExperimentalPatients 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.
Receives: Other: Very Low Calorie Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic Control

    Hemoglobin A1C

    Measured: baseline, week 12, week 24, week 48

Secondary outcomes (3)

  1. Weight lost

    Percentage of weight loss

    Measured: baseline, week 12, week 24, week 48

  2. 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.

    Measured: baseline, week 12, week 24, week 48

  3. 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.

    Measured: baseline, week 12, week 24, week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start24 Jun 2024
  3. Primary completion3 Nov 2025 (estimated)
  4. Study completion3 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control--\[GLP-1 agonist +/- DM2 meds + medical management + nutritional/behavioral counseling\] Experimental---\[Optifast + GLP-1 agonist + medical management + nutritional/behavioral counseling\]
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06363747
Sponsor's protocol ID
123456
Status last verified
Feb 2025
First submitted
9 Apr 2024
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Andreadis P, Karagiannis T, Malandris K, Avgerinos I, Liakos A, Manolopoulos A, Bekiari E, Matthews DR, Tsapas A. Semaglutide for type 2 diabetes mellitus: A systematic review and meta-analysis. Diabetes Obes Metab. 2018 Sep;20(9):2255-2263. doi: 10.1111/dom.13361. Epub 2018 Jun 10.

    PubMed 29756388

  • Ard JD, Lewis KH, Rothberg A, Auriemma A, Coburn SL, Cohen SS, Loper J, Matarese L, Pories WJ, Periman S. Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study. Obesity (Silver Spring). 2019 Jan;27(1):22-29. doi: 10.1002/oby.22303. Epub 2018 Nov 13.

    PubMed 30421863

  • Bianciardi E, Gentileschi P, Niolu C, Innamorati M, Fabbricatore M, Contini LM, Procenesi L, Siracusano A, Imperatori C. Assessing psychopathology in bariatric surgery candidates: discriminant validity of the SCL-90-R and SCL-K-9 in a large sample of patients. Eat Weight Disord. 2021 Oct;26(7):2211-2218. doi: 10.1007/s40519-020-01068-2. Epub 2020 Nov 23.

    PubMed 33226607

  • Chaudhry ZW, Doshi RS, Mehta AK, Jacobs DK, Vakil RM, Lee CJ, Bleich SN, Kalyani RR, Clark JM, Gudzune KA. A systematic review of commercial weight loss programmes' effect on glycemic outcomes among overweight and obese adults with and without type 2 diabetes mellitus. Obes Rev. 2016 Aug;17(8):758-69. doi: 10.1111/obr.12423. Epub 2016 May 26.

    PubMed 27230990

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Dar MS, Chapman WH 3rd, Pender JR, Drake AJ 3rd, O'Brien K, Tanenberg RJ, Dohm GL, Pories WJ. GLP-1 response to a mixed meal: what happens 10 years after Roux-en-Y gastric bypass (RYGB)? Obes Surg. 2012 Jul;22(7):1077-83. doi: 10.1007/s11695-012-0624-1.

    PubMed 22419108

  • Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.

    PubMed 25011946

  • Engelgau MM, Geiss LS, Saaddine JB, Boyle JP, Benjamin SM, Gregg EW, Tierney EF, Rios-Burrows N, Mokdad AH, Ford ES, Imperatore G, Narayan KM. The evolving diabetes burden in the United States. Ann Intern Med. 2004 Jun 1;140(11):945-50. doi: 10.7326/0003-4819-140-11-200406010-00035.

    PubMed 15172919

  • Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

    PubMed 20071471

  • Henry RR, Scheaffer L, Olefsky JM. Glycemic effects of intensive caloric restriction and isocaloric refeeding in noninsulin-dependent diabetes mellitus. J Clin Endocrinol Metab. 1985 Nov;61(5):917-25. doi: 10.1210/jcem-61-5-917.

    PubMed 4044780

  • Jackness C, Karmally W, Febres G, Conwell IM, Ahmed L, Bessler M, McMahon DJ, Korner J. Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and beta-cell Function in type 2 diabetic patients. Diabetes. 2013 Sep;62(9):3027-32. doi: 10.2337/db12-1762. Epub 2013 Apr 22.

    PubMed 23610060

  • Kirschner MA, Schneider G, Ertel NH, Gorman J. An eight-year experience with a very-low-calorie formula diet for control of major obesity. Int J Obes. 1988;12(1):69-80.

    PubMed 3360564

  • Lingvay I, Guth E, Islam A, Livingston E. Rapid improvement in diabetes after gastric bypass surgery: is it the diet or surgery? Diabetes Care. 2013 Sep;36(9):2741-7. doi: 10.2337/dc12-2316. Epub 2013 Mar 25.

    PubMed 23530013

  • Maney M, Tseng CL, Safford MM, Miller DR, Pogach LM. Impact of self-reported patient characteristics upon assessment of glycemic control in the Veterans Health Administration. Diabetes Care. 2007 Feb;30(2):245-51. doi: 10.2337/dc06-0771.

    PubMed 17259489

  • Mann DM, Woodward M, Ye F, Krousel-Wood M, Muntner P. Trends in medication use among US adults with diabetes mellitus: glycemic control at the expense of controlling cardiovascular risk factors. Arch Intern Med. 2009 Oct 12;169(18):1718-20. doi: 10.1001/archinternmed.2009.296. No abstract available.

    PubMed 19822830

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Very Low Calorie Diet in people with Type 2 Diabetes and Obesity, run by Durham VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Control (time frame: baseline, week 12, week 24, week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06363747, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in