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

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ClinicalTrials.gov Identifier: NCT02811575
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment
Type 2 Diabetes Other: Biopsy

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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Patients with diabetes
Patients with type 2 diabetes will have biopsy during coloscopy.
Other: Biopsy
Ileon and colon biopsy

Control
Patients without type 2 diabetes will have biopsy during coloscopy.
Other: Biopsy
Ileon and colon biopsy




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Ileon and colon biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a diagnoses of type 2 diabetes and patient who do not have a know diabetes diagnose.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811575


Contacts
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Contact: Pierre Gourdy gourdy.p@chu-toulouse.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Pierre Gourdy         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Pierre Gourdy University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02811575    
Other Study ID Numbers: RC31/16/8217
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
Coloscopy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases