Clinical trial NCT02811575: Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept
Official title: Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Coloscopy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 121
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnoses of type 2 diabetes and patient who do not have a know diabetes diagnose.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of lymphocyte TCD4 Th17 in colon sample
timeFrame: Day 1
Secondary outcomes:
measure: Number of lymphocyte TCD4 Th17 in ileon sample
timeFrame: Day 1
measure: Number of CD45+ cells in colon sample
timeFrame: Day 1
measure: Number of CD45+ cells in ileon sample
timeFrame: Day 1
measure: Activation of CD45+ cells in colon sample
timeFrame: Day 1
measure: Activation of CD45+ cells in ileon sample
timeFrame: Day 1
measure: Microbiota sequencing in blood sample
timeFrame: Day 1
measure: Microbiota quantification in blood sample
timeFrame: Day 1
measure: Microbiota sequencing in ileon sample
timeFrame: Day 1
measure: Microbiota sequencing in colon sample
timeFrame: Day 1
measure: Microbiota quantification in ileon sample
timeFrame: Day 1
measure: Microbiota quantification in colon sample
timeFrame: Day 1
measure: Bacteria production
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Pierre Gourdy
role: PRINCIPAL_INVESTIGATOR
References: