Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept
NCT ID: NCT02811575
Last Updated: 2022-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2016-12-31
2021-03-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with diabetes
Patients with type 2 diabetes will have biopsy during coloscopy.
Biopsy
Ileon and colon biopsy
Control
Patients without type 2 diabetes will have biopsy during coloscopy.
Biopsy
Ileon and colon biopsy
Interventions
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Biopsy
Ileon and colon biopsy
Eligibility Criteria
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Inclusion Criteria
* Capacity to give a written informed consent
Exclusion Criteria
* 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
35 Years
70 Years
ALL
Yes
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Pierre Gourdy
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU de Toulouse
Toulouse, , France
Countries
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Other Identifiers
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RC31/16/8217
Identifier Type: -
Identifier Source: org_study_id
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