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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how gut bacteria affect individuals with and without Type 2 Diabetes (T2D). Researchers aim to determine whether certain gut bacteria influence blood sugar control by breaking down the gut's protective barrier. Participants will undergo an endoscopy to collect samples from the upper and lower gut, including a duodenal biopsy. Individuals with or without T2D who are not taking certain medications may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on gut health and diabetes.

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 prior data suggests that this method is safe for gut bacteria analysis?

Research has shown that procedures using a thin, flexible tube to examine the body, such as taking a small tissue sample from the small intestine, are generally safe and manageable for patients. In studies on these techniques, individuals with type 2 diabetes experienced improved blood sugar control with minimal side effects. Reports indicate a low risk of serious complications, suggesting that the treatment is quite safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how gut bacteria might play a role in managing Type 2 Diabetes. Unlike standard treatments that focus on blood sugar control through medications or lifestyle changes, this method investigates the gut microbiome's influence on the condition. By analyzing gut bacteria through biopsies and samples, scientists hope to uncover new insights into how our digestive system impacts diabetes, potentially leading to innovative ways to treat or even prevent the disease.

What evidence suggests that this trial's methods could be effective for Type 2 Diabetes?

Research has shown that changes in gut bacteria are linked to type 2 diabetes. One study found that people with high blood sugar had more harmful bacteria and fewer helpful ones in their gut. This suggests that gut bacteria might affect how well the body responds to insulin, a hormone that helps control blood sugar. Another study used detailed methods to better analyze gut bacteria, which could enhance understanding of their role in diabetes. In this trial, participants with and without type 2 diabetes will undergo upper gut biopsies and lower gut sampling to study these bacteria. Researchers aim to learn how these bacteria might affect blood sugar and insulin levels. ^{6 7 8 9 10}

Who Is on the Research Team?

André Marette, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313650/

A novel method for precise endoscopic sampling ... The aim is to enhance the accuracy of microbiota analysis, providing a more reliable foundation for clinical research on gut microbiomes. 2.

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-1-2021-7413d

Gut Bacteria Analysis for Type 2 Diabetes (DBBIOTE Trial) Trial Overview The study involves an endoscopy and duodenal biopsy to explore how gut bacteria might influence type 2 diabetes by affecting insulin resistance ...

3. nature.com nature.com/articles/s41598-023-37720-x

Hyperglycemia is associated with duodenal dysbiosis and ... We found patients with hyperglycemia (n = 33) had higher duodenal bacterial count (p = 0.008), increased pathobionts and reduction in beneficial flora compared ...

4. link.springer.com link.springer.com/article/10.1007/s10620-024-08710-4

A Thorough Assessment of the Duodenal Mucosa After ... Duodenal Mucosal Resurfacing (DMR) is an endoscopic ablation technique aimed at improving glycemia in patients with type 2 diabetes mellitus (T2DM).

5. sciencedirect.com sciencedirect.com/science/article/pii/S0026049523003165

Upper small intestine microbiome in obesity and related ... This review presents current evidence regarding the relationships between the microbiome in the upper small intestine and various phenotypes, focusing on ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666634024001260

Endoscopic duodenal mucosa ablation techniques for ... All these duodenal mucosa ablation (DMA) techniques improve glucose homeostasis; DMR and ReCET appear to be safe and effective in patients with T2DM.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11920325/

From Endoscopic Inspection to Gene-Expression: A Thorough ... Duodenal Mucosal Resurfacing (DMR) is an endoscopic ablation technique aimed at improving glycemia in patients with type 2 diabetes mellitus (T2DM).

8. cell.com cell.com/med/pdf/S2666-6340(24)00126-0.pdf

Endoscopic duodenal mucosa ablation techniques for ... Type 2 diabetes mellitus (T2DM) prevalence is increasing, and only. 50% of patients with T2DM achieve or maintain adequate glycemic control with.

9. researchgate.net researchgate.net/publication/394922270_Performance_and_safety_of_duodenal_mucosal_ablation_in_the_management_of_type_2_diabetes_a_systematic_review_and_meta-analysis

Performance and safety of duodenal mucosal ablation in ... The primary outcome was mean HbA1c reduction within 6 months post-procedure and the secondary outcome was the pooled rate of serious adverse ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2949708625000354

Radiofrequency vapor ablation for duodenal mucosal ... DMA using the RFVA system is a simple through-the-scope procedure that appears safe, well tolerated, and feasible for the treatment of T2D.