Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease

NCT ID
NCT07390422
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
Chinese University of Hong Kong

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 40 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 pulsENDO or similar procedure * Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO * 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 hypothyroidism, Cushing syndrome and eating disorder. * Patients with contra-indications to endoscopy * Patients with cirrhosis due to causes other than MASLD * Malignancy * Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma) * Pregnant or breast feeding * ASA grade IV \& V * Mental or psychiatric disorder; Drug or alcohol addiction * Other cases deemed by the examining physician as unsuitable for safe treatment * Refusal to participate

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Hong Kong

Sample of listed locations

  • Chinese University of Hong Kong — Shatin, Hong Kong — Site recruitment status not specified in the registry data

Study details

Start date
September 1, 2026
Primary completion date
August 30, 2031
First posted
February 5, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07390422
Registry last updated
September 15, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07390422 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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