This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
This is a prospective, single-armed, feasibility study enrolling individuals with obesity and type 2 diabetes. Participants will be followed for a total of 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
First part - pulsENDO procedure : 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. Second part - Endoscopic sleeve gastroplasty : ESG is performed using an endoscopic suturing device (Overstitch, BSC) to reduce the stomach volume through the creation of a restrictive endoscopic sleeve. This is accomplished with around 4-7 permanent full thickness sutures over greater curve stomach in a running plication extending from the angular incisura and continuing proximally with fundal sparing.
Prince of Wales Hospital, the Chinese University of Hong Kong
Shatin, Hong Kong
RECRUITINGChange in Diabetic medications
Changes of glucose lower drugs/ insulin dosage
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 and duodenal microbiome
changes in faecal microbiome from baseline to Month 12
Time frame: 12 months post-procedure
Improvement of MAFLD
Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology
Time frame: 24 months post-procedure
HbA1c
Change in HbA1c (%) 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