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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diabetes<br>Patients with type 2 diabetes will have biopsy during coloscopy. | Other: Biopsy<br>* Ileon and colon biopsy<br>|
| Control<br>Patients without type 2 diabetes will have biopsy during coloscopy. | Other: Biopsy<br>* Ileon and colon biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lymphocyte TCD4 Th17 in colon sample | After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample. | Day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coloscopy