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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