The Role of the Thymus in Type I Diabetes.

Not Applicable

Withdrawn

• Conditions: Type1 Diabetes
• Interventions: Procedure: Blood collection

• Registration Number: NCT03236558
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Study Start: 2018-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with diabetes	Blood collection	T1D patients with blood collection

Primary Outcome Measures

Name	Time	Method
Variability of the diversity of antigen-receptors' repertoires, expressed by regulatory T cells from type I diabetes patients and healthy controls.	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

Name	Time	Method
Ratio between TCR diversities expressed by Treg cells vs. conventional T cells.	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.

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, Midi-Pyrénées, France