- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579900
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk (DBBIOTE)
August 4, 2023 updated by: André Marette, Laval University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geneviève Pilon, PhD
- Phone Number: 3783 418-656-8711
- Email: Genevieve.Pilon@criucpq.ulaval.ca
Study Locations
-
-
-
Québec, Canada, G1V 0A6
- Recruiting
- INAF, Université Laval
-
Contact:
- André Tremblay, Ph.D
- Phone Number: 411417 1-418-656-2131
- Email: andre.tremblay@fsaa.ulaval.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- T2DB de novo or non T2DB patients
Exclusion Criteria:
- oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Type 2 Diabetes patients
Upper gut biopsies and lower gut samples
|
All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples
|
Active Comparator: Non Type 2 Diabetes patients
Upper gut biopsies and lower gut samples
|
All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbial signature
Time Frame: One week
|
Compare the bacterial profile of T2D and non-T2D subjects
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: André Marette, PhD, Laval University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 7, 2020
First Posted (Actual)
October 8, 2020
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMI2 CHU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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