Pulsendo for Type 2 Diabetes and fatty liver disease in adults

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 type 2 diabetes who have not achieved adequate glycemic control with oral glucose-lowering medications. Participants will undergo the pulsENDO procedure and have liver biopsies before and after treatment to assess effects on metabolic fatty liver disease. They will be followed for 12 months to evaluate primary outcomes and for a total of 2 years, with a possible repeat pulsENDO if diabetes control recurs between years 1 and 2. An additional year of follow-up occurs after any repeat procedure. The study aims to understand safety, feasibility, and potential mechanisms related to metabolic improvements.

Why it matters

Who can join: the full rules

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

Where it's running

• Chinese University of Hong Kong
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Stephen Ng, FRCSEd(Gen) — Prince of Wales Hospital, the Chinese University of Hong Kong
• Study coordinator: Stephen Ng, FRCSEd(Gen)
• 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.