NCT06385704

Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR)

Changes in Intestinal Barrier Function and Gut Microbiome After Duodenal Mucosal Resurfacing

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wang Siqi · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiotic analysis and High Performance Liquid Chromatography (HPLC), combined with changes in clinical data.

Detailed description

This study aims to enroll 100 patients diagnosed with type 2 diabetes who have suboptimal control with one or more oral antidiabetic drugs. Of these, 50 will receive DMR treatment at the Metabolic Weight Loss Center of the China-Japan Friendship Hospital and will be followed up, while the other 50, who have not received DMR treatment, will be matched by age and gender for comparison. Each patient or their legal guardian will sign an informed consent form to participate in the study. Researchers will be granted access to the patients' medical records and will collect their medical history and treatment data. Researchers will also collect urine and fecal samples for microbiome analysis，metagenomics-based studies and HPLC, analyzing the changes in intestinal barrier function and gut microbiota before and after DMR treatment, and between DMR-treated and non-DMR-treated patients.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	DMR Procedure	Endoscopic procedure

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-04-26
• Last updated: 2024-04-30