Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06092476

Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-01-16

18

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

Sponsors

A

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

Lead Sponsor

F

Fractyl Health Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.

CONDITIONS

Official Title

Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Type 2 Diabetes.
  • Age 18 to 75 years.
  • Insulin-na�efve patients on stable doses of two or more glucose lowering drugs (including metformin, sulphonylurea, SGLT-2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or thiazolidinedione derivatives) for at least 12 weeks.
  • Body mass index (BMI) between 24 and 40 kg/m2.
  • HbA1c between 54 mmol/mol (7.5%) and 86 mmol/mol (10.0%).
  • Signed written informed consent according to Good Clinical Practice and local laws.
Not Eligible

You will not qualify if you...

  • Uncontrolled hyperglycemia with fasting glucose level >270 mg/dl (>15.0 mmol/L) confirmed on two consecutive days.
  • Current use of insulin.
  • Absolute insulin deficiency indicated by fasting plasma C-peptide <0.6 ng/ml (<0.2 nmol/L).
  • Diagnosed autoimmune diabetes, Type 1 diabetes, monogenic diabetes, or latent autoimmune diabetes.
  • History of more than one severe hypoglycemia episode requiring third-party assistance in the past 6 months.
  • Clinically significant valvular heart disease or severe aortic stenosis.
  • Acute coronary syndrome, stroke, or transient ischemic attack within the past 3 months.
  • Acute liver disease with ALT, AST, or alkaline phosphatase above 3 times the upper normal limit.
  • Active or chronic hepatitis B or C (unless hepatitis C cured), cirrhosis, hepatic decompensation in last 6 months, or alcoholic/autoimmune chronic hepatitis.
  • Impaired renal function with eGFR <45 ml/min/1.73m2, end stage renal failure, or dialysis.
  • Esophageal motility disorder or severe GERD.
  • Structural or functional stomach disorders such as ulcers, gastritis, varices, hernia, cancer.
  • Previous gastrointestinal surgery affecting duodenal treatment.
  • Known intestinal autoimmune diseases or connective tissue disorders affecting the small intestine.
  • Active Helicobacter pylori infection (previously treated infections allowed).
  • History of active malignancy or partial remission within 5 years, except certain skin cancers or those in complete remission.
  • Blood disorders causing hemolysis or unstable red blood cells (except sickle cell trait).
  • Severe peripheral vascular disease.
  • Active systemic infection.
  • Immunocompromised status including recent organ transplant, chemotherapy, radiotherapy, leukopenia, HIV infection, or immunosuppressant use.
  • Current systemic steroid treatment or recent thyroid hormone dosage changes.
  • Use of anticoagulation or antiplatelet therapy not able to be discontinued as required.
  • Participation in weight loss programs or use of weight loss medications within 3 months prior to randomization.
  • Contraindications to sedation, anesthesia, or upper GI endoscopy.
  • Nursing or pregnant women, or women unwilling to use birth control.
  • History of substance abuse.
  • Recent participation in other investigational drug or device trials within 30 days.
  • Any other clinical or mental condition that jeopardizes safety or suitability for trial participation.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands

Actively Recruiting

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Research Team

K

Kim van den Hoek, MD

CONTACT

C

Celine BE Busch, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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