Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
DBBIOTE
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Feb 2021
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 18, 2025
March 1, 2025
4.8 years
October 6, 2020
March 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Microbial signature
Compare the bacterial profile of T2D and non-T2D subjects
One week
Study Arms (2)
Type 2 Diabetes patients
EXPERIMENTALUpper gut biopsies and lower gut samples
Non Type 2 Diabetes patients
ACTIVE COMPARATORUpper gut biopsies and lower gut samples
Interventions
All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples
Eligibility Criteria
You may qualify if:
- T2DB de novo or non T2DB patients
You may not qualify if:
- oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
INAF, Université Laval
Québec, Quebec, G1V 0A6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
André Marette, PhD
Laval University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 8, 2020
Study Start
February 1, 2021
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
March 18, 2025
Record last verified: 2025-03