Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

ConditionObesity Type 2 Diabetes Mellitus

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorChinese University of Hong Kong

About this trial

This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM

Eligibility criteria

Qualifiers

BMI >/= 27kg/m2

Known T2DM

Individualized Metabolic Surgery (IMS) score 25-115

HbA1c <11% (subjects on oral glucose lowering drug(s) or HbA1c <8% (subjects on insulin)

Disqualifiers

Previous treatment with ReCET, ESG or similar procedure

Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG

Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis

Fasting C-peptide level <0.5ug/L

Trial design

Treatments tested in this trial

Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)

Treatment groups

20 Participants

are divided into 1 treatment group

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov