This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.
This is a prospective, single-arm feasibility study enrolling individuals with type 2 diabetes mellitus (T2DM) who have failed to achieve adequate glycemic control with oral glucose-lowering medications. Participants will undergo the pulsENDO procedure and liver biopsies both prior to and after the procedure to evaluate its effects on metabolically associated fatty liver disease (MAFLD). They will be followed for 12 months to assess the primary endpoint and for a total of 2 years. Participants are permitted to undergo a repeat pulsENDO procedure once if they initially respond but experience a recurrence of suboptimal diabetes management between 1 and 2 years after the procedure. They will be followed up for an additional year after the repeated procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Chinese University of Hong Kong
Shatin, Hong Kong
RECRUITINGHbA1c
Change in HbA1c (%) from baseline to Month 24
Time frame: 24 months post-procedure
Improvement of MAFLD
Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology
Time frame: 12 months post-procedure
Total body weight loss (%TBWL)
Percent total body weight loss (%TBWL) from baseline to Month 24
Time frame: 24 months post-procedure
Incidence of adverse events
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: within 30 days post-procedure
Body fat percentage
Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24
Time frame: 24 months post-procedure
Change in Quality of Life
measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24
Time frame: 24 months post-procedure
Faecal microbiome
changes in faecal microbiome from baseline to Month 24
Time frame: 24 months post-procedure
Changes in background glucose lowering medications
Changes in glucose lowering medications from baseline to Month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 24 months post-procedure