Working… Menu

Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02879383
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : February 3, 2021
Information provided by (Responsible Party):
Fractyl Laboratories, Inc.

Brief Summary:

The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for the treatment of uncontrolled type 2 diabetes.

Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham treatment arm will cross over to receive the DMR treatment at 24 weeks with background medications held constant from 24-48 weeks of follow up.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Noninsulin-Dependent Diabetes Mellitus Procedure: DMR Procedure Procedure: Sham Procedure Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DMR Procedure
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
Procedure: DMR Procedure
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Other Names:
  • DMR
  • Revita

Sham Comparator: Sham Procedure
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Procedure: Sham Procedure
The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.

Primary Outcome Measures :
  1. Change from baseline at 24 weeks in hemoglobin A1c (HbA1c), DMR vs Sham. [ Time Frame: 24 Weeks post-procedure ]
    The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham

  2. Change from baseline at 12 weeks in MR-PDFF, DMR vs Sham [ Time Frame: 12 Weeks post-procedure ]
    The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF > 5% , DMR vs Sham

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 28-75 years of age
  2. Diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion. Fasting insulin > 7 μU/ mL.
  3. Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol)
  4. Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
  5. Currently taking one or more oral glucose lowering medications of which one must be Metformin, with no changes in dose or medication in the previous 12 Weeks prior to study entry
  6. Able to comply with study requirements and understand and sign the informed consent

Exclusion Criteria:

  1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
  2. Current use of Insulin
  3. Current use of Glucagon-like peptide-1 (GLP-1) analogues
  4. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
  5. Known autoimmune disease, as evidenced by a positive Anti- Glutamic Acid Decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  6. Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.)
  7. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
  8. History of chronic or acute pancreatitis
  9. Known active hepatitis or active liver disease
  10. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
  11. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
  12. Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
  13. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
  14. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
  15. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
  16. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
  17. Persistent Anemia, defined as Hgb<10 g/dl
  18. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Diseae (MDRD) <30 ml/min/1.73m^2
  19. Active systemic infection
  20. Active malignancy within the last 5 years
  21. Not potential candidates for surgery or general anesthesia
  22. Active illicit substance abuse or alcoholism
  23. Participating in another ongoing clinical trial of an investigational drug or device
  24. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02879383

Layout table for location information
Hopital Erasme
Brussels, Belgium, 1070
UZ Leuven
Leuven, Belgium
Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo
Sao Paulo, Brazil
ABC Hospital
São Paulo, Brazil
Policlinico Gemelli (Sacro Cuore)
Rome, Lazio, Italy
Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano
Milano, Italy, 20089
Amsterdam University Medical Center
Amsterdam, Netherlands, 1105 AZ
United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
University College London Hospitals
London, United Kingdom, NW1 2BU
King's College, Denmark Hill
London, United Kingdom
Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Fractyl Laboratories, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fractyl Laboratories, Inc. Identifier: NCT02879383    
Other Study ID Numbers: C-30000
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fractyl Laboratories, Inc.:
Type 2 Diabetes, Revita System, DMR
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases