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Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

Study acronym: DBBIOTE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary and study completion dates: Dec 1, 2024 to Dec 1, 2025
    • Site details revised
    v5
  2. Primary completion date: Dec 1, 2022 to Dec 1, 2024v4
  3. Study completion date: Oct 31, 2024 to Dec 1, 2024v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2020 to Feb 1, 2021
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Laval University
86 trials monitored
See 1 trial at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at 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.
Trial Details
NCT Number NCT04579900
Lead Sponsor Laval University
Conditions
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov