RecruitingNot ApplicableNCT06092476

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

A Randomized Double-blind Sham-controlled Trial to Evaluate Efficacy+Safety of Revita Duodenal Mucosal Resurfacing (DMR) Treatment Paradigm+Retreatment in Patients With Type 2 Diabetes Using Non-insulin Glucose Lowering Medications (REMIND)


Sponsor

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

Enrollment

18 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called Revita DMR (duodenal mucosal resurfacing) — a minimally invasive endoscopic treatment that remodels the lining of the upper small intestine — to see if it helps improve blood sugar control in people with type 2 diabetes whose current medications are not enough. **You may be eligible if...** - You are 18–75 years old with type 2 diabetes - You are not using insulin - You are on 2 or more stable diabetes medications (such as metformin, SGLT-2 inhibitors, GLP-1 agonists, or DPP-4 inhibitors) at the maximum tolerated dose for at least 12 weeks - Your BMI is between 24 and 40 - Your HbA1c (long-term blood sugar marker) is between 7.5% and 10% **You may NOT be eligible if...** - Your blood sugar is dangerously high (above 270 mg/dL after fasting) - You have type 1 diabetes or severe kidney, liver, or heart disease - You have a history of stomach or intestinal surgery - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERevita® DMR Treatment

The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows: DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.

OTHERSham procedure

The sham control for the Revita DMR procedure.


Locations(1)

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands

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NCT06092476


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