Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

NCT ID: NCT04579900

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-12-01

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.

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Type 2 Diabetes patients

Upper gut biopsies and lower gut samples

Group Type: EXPERIMENTAL

Endoscopy and duodenal biopsy and sampling

Intervention Type: PROCEDURE

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

Non Type 2 Diabetes patients

Upper gut biopsies and lower gut samples

Group Type: ACTIVE_COMPARATOR

Endoscopy and duodenal biopsy and sampling

Intervention Type: PROCEDURE

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

Interventions

Endoscopy and duodenal biopsy and sampling

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• T2DB de novo or non T2DB patients

Exclusion Criteria

• oral hypoglycemic agents or lipidlowering or antihypertensive drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

André Marette

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

André Marette, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

INAF, Université Laval

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Geneviève Pilon, PhD

Role: CONTACT

Genevieve.Pilon@criucpq.ulaval.ca

418-656-8711 ext. 3783

Facility Contacts

André Tremblay, Ph.D

Role: primary

andre.tremblay@fsaa.ulaval.ca

1-418-656-2131 ext. 411417

Other Identifiers

CMI2 CHU

Identifier Type: -

Identifier Source: org_study_id