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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02811575
Acronym
SIMMUNIDIA
Enrollment
121
Registered
2016-06-23
Start date
2016-12-31
Completion date
2021-03-04
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Coloscopy

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.

Interventions

OTHERBiopsy

Ileon and colon biopsy

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of lymphocyte TCD4 Th17 in colon sampleDay 1After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026