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

Toulouse University Hospital

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02811575

RC31/16/8217

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

121 participants in 2 patient groups

Patients with diabetes

Description:

Patients with type 2 diabetes will have biopsy during coloscopy.

Treatment:

Other: Biopsy

Control

Description:

Patients without type 2 diabetes will have biopsy during coloscopy.

Treatment:

Other: Biopsy