Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Biopsy

• Registration Number: NCT02811575
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at the origin of type 2 diabetes and about its complications could make it possible to improve the prevention and the treatment of this disease.

Research team developped a new research axis : the microbiota of the intestinal mucosa. They proved a translocation process of intestinal bacteria from the intestinal mucosa to different tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes and obesity is ongoing.

In parallel, the same team explored the role of intestinal immunity modifications in the bacteria translocation from the gut to the blood circulation. They already have some results on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4 Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity development and type 2 diabetes.

The aim of this study is to explore this hypothesis in human to have therapeutic solution later.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-23
• Study Start: 2016-12
• Primary Completion: 2021-03-04
• Study Completion: 2021-03-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Coloscopy indication
• Capacity to give a written informed consent

Exclusion Criteria

• Type 1 diabetes
• Severe renal failure
• Antecedent of liver fibrosis and/or liver failure
• Antecedent of inflammatory bowel disease, lymphocyte colitis, celiac disease or colon cancer
• Antecedent of obesity surgery or of total colectomy
• Antecedent of documented intestinal ischaemia
• Acute infection the week before the inclusion
• Congenital of acquired immune deficiency
• Chronic viral infection
• Antibiotic of probiotic the month before the coloscopy
• Pregnancy
• Patients participating to another research with an exclusion period
• Patients under guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Biopsy	Patients without type 2 diabetes will have biopsy during coloscopy.
Patients with diabetes	Biopsy	Patients with type 2 diabetes will have biopsy during coloscopy.

Primary Outcome Measures

Name	Time	Method
Number of lymphocyte TCD4 Th17 in colon sample	Day 1	After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.

Secondary Outcome Measures

Name	Time	Method
Microbiota quantification in ileon sample	Day 1	Microbiota will be quantified in ileon sample
Number of CD45+ cells in colon sample	Day 1	After colon biopsy, CD45+ cells are counted in biopsy sample.
Number of CD45+ cells in ileon sample	Day 1	After ileon biopsy, CD45+ cells are counted in biopsy sample.
Microbiota sequencing in colon sample	Day 1	Microbiota will be sequencing in colon sample
Number of lymphocyte TCD4 Th17 in ileon sample	Day 1	After ileon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.
Microbiota sequencing in blood sample	Day 1	Microbiota will be sequencing in blood sample
Activation of CD45+ cells in colon sample	Day 1	After colon biopsy, CD45+ cells are analysed to see their state of activation in biopsy sample.
Microbiota sequencing in ileon sample	Day 1	Microbiota will be sequencing in ileon sample
Microbiota quantification in colon sample	Day 1	Microbiota will be quantified in colon sample
Bacteria production	Day 1	Culture of biological samples to study the bacteria production
Activation of CD45+ cells in ileon sample	Day 1	After ileon biopsy, CD45+ cells are analysed to see their state of activation in biopsy sample.
Microbiota quantification in blood sample	Day 1	Microbiota will be quantified in blood sample

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, France