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

NCT06385704 | Not Yet Recruiting

• 1 other identifier: DMRIBFGM0420
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Duodenal Mucosal Resurfacing; Intestinal Barrier Function; Gut Microbiome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

DMR Procedure

EXPERIMENTAL

Subjects receive the endoscopic DMR procedure in this arm

Procedure: DMR Procedure

Interventions

DMR Procedure PROCEDURE

Endoscopic procedure

DMR Procedure

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• Able to comply with study requirements and understand and sign the informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Wang Siqi: lead
• China-Japan Friendship Hospital: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

siqi Wang, Doctor

CONTACT

+8618810315722; rjzd280@163.com

Hua Meng, Doctor

CONTACT

menghua@zryhyy.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04