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Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk (DBBIOTE)

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ClinicalTrials.gov Identifier: NCT04579900
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
André Marette, Laval University

Study Description
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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
Type 2 Diabetes Procedure: Endoscopy and duodenal biopsy and sampling Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Microbial signature [ Time Frame: One week ]
    Compare the bacterial profile of T2D and non-T2D subjects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • T2DB de novo or non T2DB patients

Exclusion Criteria:

  • oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579900


Contacts
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Contact: Geneviève Pilon, PhD 418-656-8711 ext 3783 Genevieve.Pilon@criucpq.ulaval.ca

Locations
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Canada
INAF, Université Laval Recruiting
Québec, Canada, G1V 0A6
Contact: André Tremblay, Ph.D    1-418-656-2131 ext 411417    andre.tremblay@fsaa.ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: André Marette, PhD Laval University
More Information
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Responsible Party: André Marette, Professor, Laval University
ClinicalTrials.gov Identifier: NCT04579900    
Other Study ID Numbers: CMI2 CHU
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases