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Clinical Trials/NCT03236558
NCT03236558
Withdrawn
Not Applicable

Thymic Generation of Regulatory T Lymphocytes in Type I Diabetes Patients.

University Hospital, Toulouse1 site in 1 countryMarch 2018
ConditionsType1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type1 Diabetes
Sponsor
University Hospital, Toulouse
Locations
1
Primary Endpoint
Variability of the diversity of antigen-receptors' repertoires, expressed by regulatory T cells from type I diabetes patients and healthy controls.
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2018
End Date
March 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • legal protection

Outcomes

Primary Outcomes

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 Outcomes

  • Ratio between TCR diversities expressed by Treg cells vs. conventional T cells.(Day 1)

Study Sites (1)

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