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

Conditions: T2DM (Type 2 Diabetes Mellitus), MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome (MetS)

Sex: All

Ages: 18 Years – 70 Years

Healthy volunteers: No

Phase: NA

Enrollment: 40

Sponsor: Chinese University of Hong Kong

Summary

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Fasting C-peptide level \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07390422). StuddyBuddy aggregates publicly available trial information.