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NCT Number: NCT04579900

Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INAF, Université Laval

Québec, Quebec, G1V 0A6, Canada

Location status: Recruiting

Location contact

André Tremblay, Ph.D

CONTACT

[email protected]

1-418-656-2131 ext. 411417

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • T2DB de novo or non T2DB patients

Exclusion criteria

  • oral hypoglycemic agents or lipidlowering or antihypertensive drugs

Treatment and study plan

Endoscopy and duodenal biopsy and sampling

Procedure

All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples

Primary outcomes

  1. Microbial signature

    Time frame: One week

    Compare the bacterial profile of T2D and non-T2D subjects

Study contacts

Contact information is provided by the study sponsor or research team.

Geneviève Pilon, PhD

CONTACT

[email protected]

418-656-8711 ext. 3783

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: DBBIOTE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2020
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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