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NCT Number: NCT02811575

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Other

Ileon and colon biopsy

Primary outcomes

  1. Number of lymphocyte TCD4 Th17 in colon sample

    Time frame: Day 1

    After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.

Secondary outcomes

  1. Number of lymphocyte TCD4 Th17 in ileon sample

    Time frame: Day 1

    After ileon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.

  2. Number of CD45+ cells in colon sample

    Time frame: Day 1

    After colon biopsy, CD45+ cells are counted in biopsy sample.

  3. Number of CD45+ cells in ileon sample

    Time frame: Day 1

    After ileon biopsy, CD45+ cells are counted in biopsy sample.

  4. Activation of CD45+ cells in colon sample

    Time frame: Day 1

    After colon biopsy, CD45+ cells are analysed to see their state of activation in biopsy sample.

  5. Activation of CD45+ cells in ileon sample

    Time frame: Day 1

    After ileon biopsy, CD45+ cells are analysed to see their state of activation in biopsy sample.

  6. Microbiota sequencing in blood sample

    Time frame: Day 1

    Microbiota will be sequencing in blood sample

  7. Microbiota quantification in blood sample

    Time frame: Day 1

    Microbiota will be quantified in blood sample

  8. Microbiota sequencing in ileon sample

    Time frame: Day 1

    Microbiota will be sequencing in ileon sample

  9. Microbiota sequencing in colon sample

    Time frame: Day 1

    Microbiota will be sequencing in colon sample

  10. Microbiota quantification in ileon sample

    Time frame: Day 1

    Microbiota will be quantified in ileon sample

  11. Microbiota quantification in colon sample

    Time frame: Day 1

    Microbiota will be quantified in colon sample

  12. Bacteria production

    Time frame: Day 1

    Culture of biological samples to study the bacteria production

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: SIMMUNIDIA

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2016
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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