Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM
Recruiting now · Not applicable
Conditions studied: Obesity Type 2 Diabetes Mellitus
In brief
This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
Key facts
- Study ID
- NCT07660445
- Run by
- Chinese University of Hong Kong
- People needed
- 20
- Starts
- 2026-08-01
- Expected to finish
- 2031-07-31
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- BMI >/= 27kg/m2
- Known T2DM
- Individualized Metabolic Surgery (IMS) score 25-115
- HbA1c <11% (subjects on oral glucose lowering drug(s) or HbA1c <8% (subjects on insulin)
You may not qualify if…
- Previous treatment with ReCET, ESG or similar procedure
- Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG
- Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis
- 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 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
Where it is running
- Prince of Wales Hospital, the Chinese University of Hong Kong — Shatin, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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