Recruiting

Duodenal pulsENDO as an Early Treatment for Type 2 DM

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).

ClinicalTrials.gov IDNCT07376486
PhaseNA
Enrollment40
SponsorChinese University of Hong Kong
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

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

About this study

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).

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Duration of T2DM \</= 2 years * HbA1c \</= 7.5% * On 0-1 oral diabetes medications 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 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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.