Type 2 DiabetesDBBIOTENCT04579900
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
A study testing Endoscopy and duodenal biopsy and sampling in people with Type 2 Diabetes, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Endoscopy and duodenal biopsy and sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- T2DB de novo or non T2DB patients
Who cannot join
- oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
INAF, Université Laval
Québec, Quebec, G1V 0A6
André Tremblay, Ph.D, 1-418-656-2131 ext. 411417, andre.tremblay@fsaa.ulaval.ca
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Endoscopy and duodenal biopsy and sampling
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy and duodenal biopsy and samplingProcedure or surgery
All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes patients | Experimental | Upper gut biopsies and lower gut samples Receives: Procedure: Endoscopy and duodenal biopsy and sampling |
| Non Type 2 Diabetes patients | Active comparator | Upper gut biopsies and lower gut samples Receives: Procedure: Endoscopy and duodenal biopsy and sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial signature
Compare the bacterial profile of T2D and non-T2D subjects
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Feb 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Marette, Laval University
- Investigators
- André Marette, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579900
- Sponsor's protocol ID
- CMI2 CHU
- Acronym
- DBBIOTE
- Status last verified
- Mar 2025
- First submitted
- 6 Oct 2020
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
- ClinicalTrials.gov ID
- NCT04579900
- Acronym / sponsor ID
- DBBIOTE / CMI2 CHU
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes patients | Experimental | Procedure: Endoscopy and duodenal biopsy and samplingUpper gut biopsies and lower gut samples |
| Non Type 2 Diabetes patients | Active comparator | Procedure: Endoscopy and duodenal biopsy and samplingUpper gut biopsies and lower gut samples |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- T2DB de novo or non T2DB patients
Key exclusion criteria (1 listed)
- oral hypoglycemic agents or lipidlowering or antihypertensive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy and duodenal biopsy and samplingAll volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples | Procedure or surgery | Non Type 2 Diabetes patients, Type 2 Diabetes patients |
Primary outcome
Microbial signature
Time frame: One week
Compare the bacterial profile of T2D and non-T2D subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
André Marette, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy and duodenal biopsy and sampling in people with Type 2 Diabetes, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geneviève Pilon, PhD (418-656-8711 ext. 3783, Genevieve.Pilon@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial signature (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.