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The Role of the Thymus in Type I Diabetes. (TregDiab)

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ClinicalTrials.gov Identifier: NCT03236558
Recruitment Status : Not yet recruiting
First Posted : August 2, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Regulatory T lymphocytes play a major role in the protection from autoimmune pathology. Defects in immunosuppression mediated by these cells is therefore suspected to contribute to these diseases. This issue has very little been studied in humans.Regulatory T cells emigrated from the thymus will be isolated from the blood of patients and healthy controls. The repertoire of antigen-receptors will be analysed by high throughput sequencing and its diversity estimated using appropriate statistical models borrowed from ecology.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Procedure: Blood collection Not Applicable

Detailed Description:
In the thymus of an animal model of type I diabetes, the population of regulatory T cells expresses a repertoire of antigen receptors that is approximately ten-fold less diverse than that found in mice resistant to autoimmune pathology. Genetic models later showed that this reduced diversity was involved in the susceptibility to diabetes. Researchers study the diversity of the TCR expressed by regulatory T cells from paediatric type I diabetes patients and controls. Regulatory T cells emigrated from the thymus will be isolated from the blood of patients and healthy controls. The repertoire of antigen-receptors will be analysed by high throughput sequencing and its diversity estimated using appropriate statistical models borrowed from ecology.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Thymic Generation of Regulatory T Lymphocytes in Type I Diabetes Patients.
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Patients with diabetes
T1D patients with blood collection
Procedure: Blood collection
Ten cc of peripheral blood will be taken from patients and healthy controls as soon as possible after T1D diagnosis of the former.




Primary Outcome Measures :
  1. Variability of the diversity of antigen-receptors' repertoires, expressed by regulatory T cells from type I diabetes patients and healthy controls. [ Time Frame: Day 1 ]
    Treg from the pediatric patients and the control subjects' blood will be isolated by cytometry, the messenger ribonucleic acid (mRNA) of these cells will be isolated, and the analysis of the alpha and beta chains of the TCRs will be carried out by high-throughput sequencing.


Secondary Outcome Measures :
  1. Ratio between TCR diversities expressed by Treg cells vs. conventional T cells. [ Time Frame: Day 1 ]
    Treg from the pediatric patients and the control subjects' blood will be isolated by cytometry, the mRNA of these cells will be isolated, and the analysis of the alpha and beta chains of the TCRs will be carried out by high-throughput sequencing.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • type I diabetes patient
  • having at least one age-matched sibling (healthy control)

Exclusion Criteria:

  • other immunopathology
  • treatment with any anti-inflammatory or immunosuppressive drugs
  • puberty
  • legal protection

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): NCT03236558


Contacts
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Contact: Claire Le Tallec, MD 5 34 55 85 79 ext 33 letallec.c@chu-toulouse.fr
Contact: Françoise Auriol 5 67 77 10 95 ext 33 auriol.f@chu-toulouse.fr

Locations
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France
CHU de Toulouse Not yet recruiting
Toulouse, Midi-Pyrénées, France, 31059
Contact: Claire Le Tallec, MD    5 34 55 85 79 ext 33    letallec.c@chu-toulouse.fr   
Contact: Françoise Auriol    5 67 77 10 95 ext 33    auriol.f@chu-toulouse.fr   
Principal Investigator: Claire Le Tallec, MD         
Sub-Investigator: Carole Morin, MD         
Sub-Investigator: Zeina Ajaltouni, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de la Recherche Scientifique, France
Investigators
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Principal Investigator: Claire Le Tallec, MD CHU Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03236558     History of Changes
Other Study ID Numbers: 16/8254
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Type 1 diabetes
Juvenile diabetes
Immune-tolerance
Regulatory T lymphocyte
Treg
TCR
Repertoire

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases