Could a gut procedure help control diabetes? new trial investigates

NCT ID NCT04419779

Disease control Sponsor: Fractyl Health Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a procedure called duodenal mucosal resurfacing (DMR) using the Revita system in people with type 2 diabetes whose blood sugar is not well controlled with medication. About 320 adults will be randomly assigned to receive either the real procedure or a sham (fake) procedure to see if DMR improves blood sugar levels. The goal is to find a new way to help manage diabetes, but it is not a cure.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Subjects must meet all of the following criteria for inclusion in the study: 1. Males and non-pregnant non-lactating females 2. Age between 21 and 70 years (both inclusive) 3. Subjects on at least one glucose lowering agent (GLA) with no changes in GLA medications or dosing for at least 12 weeks prior to the screening visit Permitted GLAs include: * Metformin, * GLP-1 RA including dual peptide agonists and related molecules (e.g., GLP-1/GIP RA), * DPP-4i, * TZDs, * SGLT2is, * SUs, * Meglitinides, * Insulin (basal or basal combined with short-acting), up to a total of 100 units daily 4. HbA1c of 7.5%-10% (both inclusive) 5. BMI \>24 to ≤40 kg/m2 6. WOCBP should have a negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration 7. Able to sign an ICF and comply with study requirements Exclusion Criteria Subjects who meet any of the following exclusion criteria are not allowed to be included in the study: 1. FPG ≥270 mg/dL 2. Known case of absolute insulin deficiency as indicated by clinical assessment or a fasting plasma C-peptide of \<0.6 ng/mL 3. Subjects on any other class of glucose-lowering agents other than GLAs listed in inclusion criteria Any drugs or concomitant medications (e.g., psychoactive drugs such as carbamazepine phenobarbital; sympathomimetics such as ephedrine corticosteroids; anabolic steroids and male sex hormones such as testosterone) that can interfere with glucose metabolism (refer to prohibited medication on Appendix D: Eligibility Criteria Checklist) 4. Recurrent or severe urinary tract or genital mycotic infections or history of GU infection within 4 weeks prior to informed consent, for those subjects on SGLT-2 5. ALT or AST \>3 times upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN. 6. Use of an investigational drug within 1 month or 5 half-lives (whichever is longer) before screening 7. Diagnosed with type 1 diabetes or with a recent history of DKA within one year prior to screening 8. Ketosis-prone T2D 9. Known diabetes related non-healing ulcers or amputations (with the exception of a finger or toe amputation occurring \> 1 year prior to screening. 10. History of more than 1 severe hypoglycemia episode or hypoglycemia unawareness within the last 6 months 11. Clinically significant hypoglycemia occurring during the run-in period, defined as a) 2 or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear, correctable, precipitating factor can be identified; b) clinically significant hypoglycemia with self-monitored or laboratory plasma glucose level \<54 mg/dL (3.0 mmol/L); or c) severe hypoglycemic episode requiring third party assistance 12. Known intestinal autoimmune disease including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder that affects the small intestine 13. Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid stimulating hormone \[TSH\] value outside the normal range at screening as determined by the central laboratory). 14. Known thyroid cancer or hyperthyroidism with treatment within the past 12 months or inadequately controlled hyperthyroidism (TSH value outside the normal range at screening as determined by the central laboratory). 15. An uncontrolled endocrine condition such as multiple endocrine neoplasia (except T2D) 16. Known structural or functional disorder of the esophagus including any swallowing disorder, esophageal chest pain disorders, drug-refractory esophageal reflux symptoms, or active and uncontrolled gastroesophageal reflux disease (GERD) (defined as Los Angeles Grade C or D esophagitis) 17. Known structural or functional disorder of the stomach including active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or type II and higher paraoesophageal hernia), cancer, or any other disorder of the stomach 18. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve, or other similar procedures or conditions 19. Known history of chronic pancreatitis or a recent history of acute pancreatitis within the past year 20. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis, hepatic decompensation/acute liver disease during the last 6 months, or alcoholic or autoimmune chronic hepatitis 21. Symptomatic gallstones, symptomatic kidney stones, or acute cholecystitis 22. Clinically active systemic infection 23. Known immunocompromised status including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months; have clinically significant leukopenia; are positive for the human immunodeficiency virus (HIV); are on potential immunosuppressants; or individuals whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the investigator 24. Known active malignancy or partial remission from clinically significant malignancy within the past 5 years (except basal or squamous cell skin cancer, carcinoma in situ, those who received curative treatment and are in complete remission for 5 years, or if the subject is confirmed as cancer free) 25. Known active coagulopathy or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia 26. Known cases of sickle cell anemia, thalassemia, or conditions that affect red blood cell (RBC) turnover such as a recent blood transfusion within 90 days. Current persistent anemia, defined as hemoglobin \<10g/dL 27. Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants \[NOACs\]) or anti-platelet agents (e.g., thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure 28. Use of systemic glucocorticoids (excluding topical or ophthalmic applications or inhaled forms) for more than 10 consecutive days within 90 days prior to screening 29. Use of non-GLA drugs known to affect GI motility (e.g., metoclopramide) 30. Known moderate to severe chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2 (estimated by Modification of Diet in Renal Disease \[MDRD\]), end-stage renal failure, or on dialysis 31. History of myocardial infarction, stroke, transient ischemic attack, coronary artery intervention, CHF exacerbation, or any other major cardiac event requiring hospitalization within the last 6 months prior to screening or any cardiac history that would deem subject not eligible for anesthesia (unless documented clearance by cardiologist and/or treating endoscopy team) 32. History of new or worsening signs or symptoms of coronary heart disease (CHD) within the last 3 months 33. Known case of severe peripheral vascular disease, defined as AMA Criteria Class 1 or greater75 (Appendix 19.8) 34. Known case of symptomatic heart failure with reduced ejection fraction (NYHA Class II-IV) requiring pharmacologic therapy to control symptoms 35. Clinically significant electrocardiogram (ECG) findings such as new clinically significant arrhythmia, ST segment changes, or other conduction disturbances that increase risk of heart disease and require intervention as determined by the investigator 36. Subjects who are at risk of pancreatitis, particularly those with a recent fasting triglyceride value of \>600 mg/dL within the past 3 months 37. Actively participating in a weight-loss program and currently not in the maintenance phase 38. General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy 39. History of substance use disorder based on the DSM-5 criteria76 within the last 12 months (American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). 40. Use of weight loss medication such as Meridia, Xenical, over-the-counter weight-loss medications, or other prescribed medications used specifically for the purpose of weight loss 41. Use of dietary supplements or herbal preparations that may have unknown effects on glycemic control or risk of bleeding 42. Participating in another ongoing clinical trial of an investigational drug or device 43. History of non-adherence to treatment in the previous 6 months, as determined by the investigator based on patient history, HbA1c value, or drug accountability 44. Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical-trial participation. Physical conditions assessed via endoscopy prior to participant study enrollment at visit 4 include, but not limited to: 1. Active and uncontrolled gastroesophageal reflux disease (GERD) defined as Los Angeles Grade C or D esophagitis 2. Abnormalities of the GI tract preventing endoscopic access to the duodenum 3. Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy 4. Malignancy newly diagnosed by endoscopy 5. Upper GI conditions (esophageal, gastric, or intestinal) such as clinically significant ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia, or other conditions listed under exclusion criteria 45. Unwilling or unable to comply with study visits and other study procedures as required per protocol 46. Recovered from severe COVID-19 infection (requiring hospitalization) but with persistent long COVID-19 symptoms (i.e., the individual has not recovered for several weeks or months since the start of symptoms that were suggestive of COVID-19, irrespective if the individual was tested or not)

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Conditions

The condition(s) this trial relates to.

diabetes mellitus endocrine system disorder glucose metabolism disease metabolic disease type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

58 sites in 7 countries. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AHN - Avon

Avon, Indiana, 46123, United States
AHN - Greenfield

Greenfield, Indiana, 46140, United States
AHN - Muncie

Muncie, Indiana, 47304, United States
AHN- Franklin

Franklin, Indiana, 46131, United States
AcellaCare Piedmont

Statesville, North Carolina, 28625, United States
AcellaCare Salisbury

Salisbury, North Carolina, 28144, United States
AcellaCare Wilmington

Wilmington, North Carolina, 28401, United States
Advent Health Orlando

Orlando, Florida, 32804, United States
Alcanza Clinical Research, LLC

Methuen, Massachusetts, 01844, United States
Angel City Research , Inc.

Los Angeles, California, 90010, United States
Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States
Biopharma Informatic, Llc

Houston, Texas, 77089, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Care Access Santa Clarita

Newhall, California, 91321, United States
Care Access Warwick

Warwick, Rhode Island, 02886-4463, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Cleveland Clinic London

London, England, SW1X &AW, United Kingdom
Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, Belgium
Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Endocrine Associates of West Village

Long Island City, New York, 77089, United States
Helios CR, Inc

Phoenix, Arizona, 85028, United States
Hoag Hospital

Newport Beach, California, 92663, United States
HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States
IMA Clinical Research St. Louis

St Louis, Missouri, 63117, United States
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States
Investigators Research Group

Brownsburg, Indiana, 46112, United States
Italy Gemelli

Roma, Italy
Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States
Jefferson City Medical Group

Jefferson City, Missouri, 65109, United States
King's College Hospital

London, United Kingdom
M3 Wake Research

Raleigh, North Carolina, 27612, United States
Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States
Mills Peninsula Health Center

San Mateo, California, 94401, United States
NYU Langone Gastroenterology Associates

New York, New York, 10016, United States
Northeast Research Institute, Llc

Fleming Island, Florida, 32003, United States
Northwestern Unviersity

Evanston, Illinois, 60611, United States
Preferred PCP - Pittsburgh

Pittsburgh, Pennsylvania, 15201, United States
Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15236, United States
Seattle Cancer Care Alliance

Seattle, Washington, 98104, United States
Simcare Medical Research, Llc.

Sugar Land, Texas, 77478, United States
Stanford University Medical Center

Redwood City, California, 94063, United States
Synexus Clinical Research, New York

New York, New York, 10017, United States
Synexus Research

Orlando, Florida, 32806, United States
Tulane University

New Orleans, Louisiana, 70112, United States
UCLA Health

Los Angeles, California, 90095, United States
Universiteit Van Amsterdam Academisch Medisch Centrum

Amsterdam, Netherlands
University College Dublin

Dublin, Ireland
University Hospital Zurich

Zurich, CH-8091, Switzerland
University of Louisville

Louisville, Kentucky, 40202, United States
University of Miami

Miami, Florida, 33136, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Weill Cornell Medicine

New York, New York, 10065, United States
West Orange Endocrinology

Ocoee, Florida, 34761, United States
West Virginia University

Morgantown, West Virginia, 26506, United States

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