Endoscopic sleeve plus pulsENDO in obese adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm feasibility study enrolling adults with obesity and type 2 diabetes. Participants will undergo combined ESG and pulsENDO procedures and will be followed for 2 years to assess safety, feasibility, and potential mechanisms of action. The study aims to provide initial data on how well this combined endoscopic approach works in improving metabolic outcomes. Tests will monitor adverse events, glycemic control, and related metabolic markers. Enrollment is at Prince of Wales Hospital, The Chinese University of Hong Kong, with lead sponsor CUHK.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• Prince of Wales Hospital, the Chinese University of Hong Kong
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Stephen Ng — Prince of Wales Hospital, the Chinese University of Hong Kong
• Study coordinator: Stephen Ng
• Email: stephenng@surgery.cuhk.edu.hk
• Phone: +85235052956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.