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

Laval University

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Procedure: Endoscopy and duodenal biopsy and sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04579900

CMI2 CHU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• T2DB de novo or non T2DB patients

Exclusion criteria

• oral hypoglycemic agents or lipidlowering or antihypertensive drugs

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Type 2 Diabetes patients

Experimental group

Description:

Upper gut biopsies and lower gut samples

Treatment:

Procedure: Endoscopy and duodenal biopsy and sampling

Non Type 2 Diabetes patients

Active Comparator group

Description:

Upper gut biopsies and lower gut samples

Treatment:

Procedure: Endoscopy and duodenal biopsy and sampling