DBBIOTE: Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

Sponsor
Laval University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04579900
Collaborator
(none)
40
1
2
46
0.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopy and duodenal biopsy and sampling
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Type 2 Diabetes patients

Upper gut biopsies and lower gut samples

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

Active Comparator: Non Type 2 Diabetes patients

Upper gut biopsies and lower gut samples

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

Outcome Measures

Primary Outcome Measures

  1. Microbial signature [One week]

    Compare the bacterial profile of T2D and non-T2D subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • T2DB de novo or non T2DB patients
Exclusion Criteria:
  • oral hypoglycemic agents or lipidlowering or antihypertensive drugs

Contacts and Locations

Locations

Site City State Country Postal Code
1 INAF, Université Laval Québec Canada G1V 0A6

Sponsors and Collaborators

  • Laval University

Investigators

  • Principal Investigator: André Marette, PhD, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
André Marette, Professor, Laval University
ClinicalTrials.gov Identifier:
NCT04579900
Other Study ID Numbers:
  • CMI2 CHU
First Posted:
Oct 8, 2020
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022