Gut Bacteria Analysis for Type 2 Diabetes

(DBBIOTE Trial)

Overseen By Geneviève Pilon, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Oral hypoglycemics, Lipid-lowering, Antihypertensives

Disqualifiers: Obesity, Type 2 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking oral hypoglycemic agents, lipid-lowering drugs, and antihypertensive drugs to participate in this trial.

What data supports the effectiveness of the treatment Endoscopy and duodenal biopsy and sampling for Type 2 Diabetes?

Research shows that changes in gut bacteria, particularly in the duodenum (the first part of the small intestine), are linked to blood sugar levels and inflammation in people with high blood sugar. This suggests that analyzing gut bacteria through endoscopy and duodenal biopsy could help understand and potentially manage Type 2 Diabetes. ^{1 2 3 4 5}

Is the procedure of endoscopy and duodenal biopsy safe for humans?

The research articles provided do not contain specific safety data for the procedure of endoscopy and duodenal biopsy in humans. ^{1 2 6 7 8}

How does the treatment of endoscopy and duodenal biopsy for Type 2 Diabetes differ from other treatments?

This treatment is unique because it involves directly examining and sampling the gut bacteria in the small intestine, which may provide insights into how gut bacteria influence Type 2 Diabetes. Unlike standard treatments that focus on managing blood sugar levels, this approach aims to understand the role of gut microbiota in the disease's development. ^{3 4 9 10 11}

What is the purpose of this trial?

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.

Research Team

André Marette, PhD

Principal Investigator

Laval University

Eligibility Criteria

This trial is for individuals who have been newly diagnosed with type 2 diabetes or those without the disease. Participants should not be taking any oral medications for lowering blood sugar, cholesterol, or blood pressure.

Inclusion Criteria

Patients with newly diagnosed type 2 diabetes or patients who do not have type 2 diabetes will not be included.

Exclusion Criteria

I am taking medication for diabetes, high cholesterol, or high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Upper gut biopsies and lower gut samples are collected from participants

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

4 weeks

Treatment Details

Interventions

• Endoscopy and duodenal biopsy and sampling

Trial Overview The study involves an endoscopy and duodenal biopsy to explore how gut bacteria might influence type 2 diabetes by affecting insulin resistance and glucose tolerance.

Participant Groups

Group I: Type 2 Diabetes patients Experimental Treatment 1 Intervention

Upper gut biopsies and lower gut samples

Group II: Non Type 2 Diabetes patients Active Control 1 Intervention

Upper gut biopsies and lower gut samples

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Human gut microbiota after bariatric surgery alters intestinal morphology and glucose absorption in mice independently of obesity. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Hyperglycemia is associated with duodenal dysbiosis and altered duodenal microenvironment. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Multi-omics analyses with stool-type stratification in patient cohorts and Blautia identification as a potential bacterial modulator in T2DM. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Correlation analysis between type 2 diabetes and core gut microbiota]. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A specific gut microbiota signature is associated with an enhanced GLP-1 and GLP-2 secretion and improved metabolic control in patients with type 2 diabetes after metabolic Roux-en-Y gastric bypass. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

The impact of dietary, surgical, and pharmacological interventions on gut microbiota in individuals with diabetes mellitus: A systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Alterations of Gut Microbiota in Type 2 Diabetes Individuals and the Confounding Effect of Antidiabetic Agents. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Acarbose on the Gut Microbiota of Prediabetic Patients: A Randomized, Double-blind, Controlled Crossover Trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Could dysbiosis of inflammatory and anti-inflammatory gut bacteria have an implications in the development of type 2 diabetes? A pilot investigation. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Type 2 diabetes influences bacterial tissue compartmentalisation in human obesity. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

High-Resolution Taxonomic Characterization Reveals Novel Human Microbial Strains with Potential as Risk Factors and Probiotics for Prediabetes and Type 2 Diabetes. [2023]