Duodenal ReCET for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (NCT07390422) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Duodenal ReCET for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease
Hong Kong40 participantsStarted 2026-04-01
Plain-language summary
This study is designed to evaluate the efficacy, safety, and mechanisms of ReCET procedure in patients with T2DM and its effect on MASLD.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Duration of T2DM \< 10 years
* BMI 18.5-40kg/m2
* Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs
Exclusion Criteria:
* Previous treatment with ReCET or similar procedure
* Previous GI surgery that could preclude the ability to perform ReCET, or acute gastric and duodenal pathology that increased the risk of ReCET
* Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis
* Patients on insulin
* Fasting C-peptide level \<0.5ug/L
* Any inflammatory disease of the gastrointestinal tract such as Crohn's disease
* Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy
* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and/or there is a need or expected need to use during the study period
* Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
* Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month
* Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyr…