Health Trials

Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease

ConditionsT2DM (Type 2 Diabetes Mellitus)MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Syndrome (MetS)
Trial statusNot yet recruiting
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 pulsENDO procedure in patients with T2DM and its effect on MASLD.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • pulsENDO treatment

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov