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

Type 2 Diabetes Clinical Trial

— SIMMUNIDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811575
• Other study ID #: RC31/16/8217
• Status: Completed
• Start date: December 2016
• Est. completion date: March 4, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Biopsy
Ileon and colon biopsy

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lymphocyte TCD4 Th17 in colon sample	After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.	Day 1
Secondary	Number of lymphocyte TCD4 Th17 in ileon sample	After ileon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.	Day 1
Secondary	Number of CD45+ cells in colon sample	After colon biopsy, CD45+ cells are counted in biopsy sample.	Day 1
Secondary	Number of CD45+ cells in ileon sample	After ileon biopsy, CD45+ cells are counted in biopsy sample.	Day 1
Secondary	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
Secondary	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
Secondary	Microbiota sequencing in blood sample	Microbiota will be sequencing in blood sample	Day 1
Secondary	Microbiota quantification in blood sample	Microbiota will be quantified in blood sample	Day 1
Secondary	Microbiota sequencing in ileon sample	Microbiota will be sequencing in ileon sample	Day 1
Secondary	Microbiota sequencing in colon sample	Microbiota will be sequencing in colon sample	Day 1
Secondary	Microbiota quantification in ileon sample	Microbiota will be quantified in ileon sample	Day 1
Secondary	Microbiota quantification in colon sample	Microbiota will be quantified in colon sample	Day 1
Secondary	Bacteria production	Culture of biological samples to study the bacteria production	Day 1