Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

February 12, 2024 updated by: Fractyl Health Inc.

Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes

The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hôpital Erasme
      • Leuven, Belgium
        • UZ Leuven
  • Chile
      • Santiago, Chile
        • Centro Clinico de Obesidad
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academic Medical Center
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. 28 -75 years of age
  2. Diagnosed with Type 2 Diabetes for less than 10 years
  3. HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
  4. Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
  5. On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry
  6. Willing to comply with study requirements and able to understand and comply with informed consent
  7. Sign an informed consent form

Exclusion Criteria

  1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
  2. Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l)
  3. Current use of Insulin
  4. Use of Glucagon like peptide (GLP)-1 analogues
  5. Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
  6. 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
  7. Previous gastrointestinal (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 (clopidrogel, 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 mg/dl
  18. Estimated glomerular filtration rate (eGFR) or Modification of Diet in Renal Disease (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. Those who are pregnant, nursing or expect to become pregnant over the course of the study
  24. Participating in another ongoing clinical trial
  25. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMR Procedure
Subjects receive the endoscopic DMR procedure in this arm
Device: DMR Procedure (Fractyl)
Endoscopic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
Time Frame: 24 weeks post-procedure
24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Time Frame: 24 weeks post-procedure
24 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fractyl Health Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2015

Primary Completion (Actual)

June 12, 2017

Study Completion (Actual)

September 18, 2019

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimated)

April 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-20000 A & B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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