Duodenal pulsENDO as an Early Treatment for Type 2 DM

Starting soon · Not applicable

Conditions studied: Diabete Mellitus, T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

In brief

This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

Key facts

Study ID

NCT07376486

Run by

Chinese University of Hong Kong

People needed

40

Starts

2026-09-01

Expected to finish

2032-08-30

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Duration of T2DM </= 2 years
• HbA1c </= 7.5%
• On 0-1 oral diabetes medications

You may not qualify if…

• 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 I 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 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
• 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

• Chinese University of Hong Kong — Shatin, Hong Kong

Full record on ClinicalTrials.gov

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