Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk (DBBIOTE)
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endoscopy and duodenal biopsy and sampling
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- T2DB de novo or non T2DB patients
Exclusion Criteria:
- oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Sites / Locations
- INAF, Université LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Type 2 Diabetes patients
Non Type 2 Diabetes patients
Arm Description
Upper gut biopsies and lower gut samples
Upper gut biopsies and lower gut samples
Outcomes
Primary Outcome Measures
Microbial signature
Compare the bacterial profile of T2D and non-T2D subjects
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04579900
Brief Title
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
Acronym
DBBIOTE
Official Title
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 2 Diabetes patients
Arm Type
Experimental
Arm Description
Upper gut biopsies and lower gut samples
Arm Title
Non Type 2 Diabetes patients
Arm Type
Active Comparator
Arm Description
Upper gut biopsies and lower gut samples
Intervention Type
Procedure
Intervention Name(s)
Endoscopy and duodenal biopsy and sampling
Intervention Description
All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples
Primary Outcome Measure Information:
Title
Microbial signature
Description
Compare the bacterial profile of T2D and non-T2D subjects
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
T2DB de novo or non T2DB patients
Exclusion Criteria:
oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geneviève Pilon, PhD
Phone
418-656-8711
Ext
3783
Email
Genevieve.Pilon@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Marette, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
INAF, Université Laval
City
Québec
ZIP/Postal Code
G1V 0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Tremblay, Ph.D
Phone
1-418-656-2131
Ext
411417
Email
andre.tremblay@fsaa.ulaval.ca
12. IPD Sharing Statement
Learn more about this trial
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
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