This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.
Duration of T2DM < 10 years
BMI 18.5-40kg/m2
Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs
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 1 DM, DM secondary to specific disease or having any history of ketoacidosis
Patients on insulin
Single group
pulsENDO treatment
Procedure/SurgeryThe 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.
HbA1c
Change in HbA1c (%) from baseline to Month 24
Improvement of MAFLD
Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology
Total body weight loss (%TBWL)
Percent total body weight loss (%TBWL) from baseline to Month 24
Incidence of adverse events
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Body fat percentage
Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24
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
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