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
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
- Procedure: pulsENDO treatment — The pulsENDO procedure utilizes the pulsENDO catheter to deliver non-thermal pulsed electric field to the duodenum to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated.
Primary outcomes
- HbA1c ≤6.5% without glucose lowering drugs (6 months post-procedure)
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
- Chinese University of Hong Kong, Shatin, Hong Kong
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.