Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

Type 2 Diabetes Clinical Trial

— DBBIOTE  

Official title:

Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579900
• Other study ID #: CMI2 CHU
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Laval University
• Contact: Geneviève Pilon, PhD
• Phone: 418-656-8711
• Email: Genevieve.Pilon[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is now well documented that changes in gut microbiota composition accompany obesity and type 2 diabetes (T2D) and contribute to low-grade inflammation, insulin resistance,and glucose intolerance. It is not yet clear if T2D predisposes the intestine to allow more microbial products or possibly live bacteria to subvert the gut mucosal barrier. However, it is known that hyperglycemia during T2D induces a more permissive gut barrier allowing increased penetration of microbes and their products into the blood. An important next step is to determine which strains of bacteria promote dysbiosis, allowing bacteria or bacterial components to subvert the gut barrier and alter glucose control. It is hypothesized that gut microbes in the colon and other lower gut segments are key modulators of energy balance, glucose homeostasis and insulin sensitivity.

Description:

The gut acts as a barrier to bacteria and nutrients and participates in glucose homeostasis via endocrine actors and the gut-brain-peripheral axis. It is unclear how T2D alters microbes in upper and lower intestine of humans. Studies in animals show that T2D promotes translocation of microbes to the blood and tissues to promote metabolic dysfunction. It is crucial to determine whether bacteria or their components subvert the gut barrier in human T2D, and then to identity the relevant bacterial strains in tissues that control blood glucose. The overall objective of our research program is to demonstrate that specific microbes in the gut, circulation, and key metabolic tissues are involved in the progression of T2D. We will define the microbial signatures of T2D in duodenal biopsies and stool samples by comparing T2D and non-T2D subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• T2DB de novo or non T2DB patients

Exclusion Criteria:

• oral hypoglycemic agents or lipidlowering or antihypertensive drugs

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Endoscopy and duodenal biopsy and sampling
All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples

Locations

Country	Name	City	State
Canada	INAF, Université Laval	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial signature	Compare the bacterial profile of T2D and non-T2D subjects	One week