This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).
This is a prospective, single-armed, feasibility study enrolling individuals with a recent diagnosis of type 2 diabetes. Participants will be followed for 6 months for the primary endpoint and 2 years in total.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The ReCET procedure utilizes the ReCET 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
HbA1c ≤6.5% without glucose lowering drugs
Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs
Time frame: 6 months post-procedure
HbA1c
Change in HbA1c (%) from baseline to Month 24
Time frame: 24 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
Hepatic steatosis index
level from baseline to Month 24
Time frame: 24 months post-procedure
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