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

NCT ID: NCT02879383

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-12-20

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.

Detailed Description

The study is a multi-center, randomized, prospective, double-blinded (subject and endocrinologist) trial of type 2 diabetes patients sub-optimally controlled on 1 or more oral anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure. Randomization will be 1:1 DMR treatment to sham. All subjects will participate in a 4 week oral anti-diabetic medication run-in period before the index procedure to confirm lack of blood glucose control in conjunction with medication compliance and nutritional counseling. The Sham treatment arm will cross-over to receive the DMR treatment at 24 weeks with background medications held constant 24weeks of follow up after the cross-over DMR procedure. The DMR treatment arm will be managed according to current diabetes standard of care.

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.

Conditions

Diabetes Mellitus, Type 2; Noninsulin-Dependent Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DMR Procedure

Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.

Group Type: EXPERIMENTAL

DMR Procedure

Intervention Type: PROCEDURE

The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System

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.

Group Type: SHAM_COMPARATOR

Sham Procedure

Intervention Type: PROCEDURE

The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.

Interventions

DMR Procedure

The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

DMR; Revita

Eligibility Criteria

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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fractyl Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geltrude Mingrone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gemelli University Hospital, Rome

Jacques Bergman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Hopital Erasme

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

ABC Hospital

São Paulo, , Brazil

Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo

São Paulo, , Brazil

Policlinico Gemelli (Sacro Cuore)

Rome, Lazio, Italy

Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano

Milan, , Italy

Amsterdam University Medical Center

Amsterdam, , Netherlands

Glasgow Royal Infirmary

Glasgow, , United Kingdom

University College London Hospitals

London, , United Kingdom

King's College, Denmark Hill

London, , United Kingdom

Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road

Nottingham, , United Kingdom

Countries

Belgium; Brazil; Italy; Netherlands; United Kingdom

References

Mingrone G, van Baar AC, Deviere J, Hopkins D, Moura E, Cercato C, Rajagopalan H, Lopez-Talavera JC, White K, Bhambhani V, Costamagna G, Haidry R, Grecco E, Galvao Neto M, Aithal G, Repici A, Hayee B, Haji A, Morris AJ, Bisschops R, Chouhan MD, Sakai NS, Bhatt DL, Sanyal AJ, Bergman JJGHM; Investigators of the REVITA-2 Study. Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial. Gut. 2022 Feb;71(2):254-264. doi: 10.1136/gutjnl-2020-323608. Epub 2021 Feb 17.

Reference Type: DERIVED

PMID: 33597157 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C-30000

Identifier Type: -

Identifier Source: org_study_id