Clinical Trial

Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

Study acronym: DBBIOTE
Recruiting
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Record status
This record was last updated March 18, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-10-07; most recent amendment 2025-03-13.
Status change: Not Yet Recruiting → Recruiting 2021-02-16
Trial Details
NCT Number NCT04579900
Lead Sponsor Laval University
Conditions Type 2 Diabetes
Enrollment 40 participants
Start Date 2021-02-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-18