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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Procedure: DMR Procedure

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: siqi Wang, Doctor; Phone Number: +8618810315722; Email: rjzd280@163.com
• Study Contact Backup: Name: Hua Meng, Doctor; Email: menghua@zryhyy.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 1.25-65 years of age. 2.Diagnosed with type 2 diabetes. 3.Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol). 4.Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2. 5.Currently taking one or more oral glucose lowering medications, with no changes in dose or medication in the previous 12 Weeks prior to study entry.

6.Able to comply with study requirements and understand and sign the informed consent.

Exclusion Criteria:

1. Clinical diagnosis of type 1 diabetes.
2. Current use of Glucagon-like peptide-1 (GLP-1) analogues.
3. Hypoglycemia unawareness or a history of severe hypoglycemia.
4. Clinical diagnosis of autoimmune disease.
5. Previous gastrointestinal surgery that could affect the ability to treat the duodenum.
6. Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure.
7. Clinical diagnosis of anemia.
8. Not potential candidates for surgery or general anesthesia.
9. Participating in another ongoing clinical trial of an investigational drug or device.
10. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DMR Procedure; Subjects receive the endoscopic DMR procedure in this arm	Procedure: DMR Procedure; Endoscopic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome Analysis	Characterization of of gut microbiome using next generation sequencing technology	one week and one month post-treatment
High Performance Liquid Chromatography	Intestinal barrier function using HPLC technology	one week and one month post-treatment

Collaborators and Investigators

• Sponsor: Wang Siqi
• Collaborators: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Duodenal Mucosal Resurfacing; Gut Microbiome; Intestinal Barrier Function
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DMRIBFGM0420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes