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

Type 2 Diabetes Mellitus Clinical Trial

— DMR-IBF-GM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385704
• Other study ID #: DMRIBFGM0420
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: China-Japan Friendship Hospital
• Contact: siqi Wang, Doctor
• Phone: +8618810315722
• Email: rjzd280[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• DMR Procedure
Endoscopic procedure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wang Siqi	China-Japan Friendship Hospital

Outcome

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