NCT03236558

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

July 28, 2017

Last Update Submit

March 30, 2020

Conditions

Type1 Diabetes

Keywords

Type 1 diabetesJuvenile diabetesImmune-toleranceRegulatory T lymphocyteTregTCRRepertoire

Outcome Measures

Primary Outcomes (1)

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

    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.

    Day 1

Secondary Outcomes (1)

  • Ratio between TCR diversities expressed by Treg cells vs. conventional T cells.

    Day 1

Study Arms (1)

Patients with diabetes

EXPERIMENTAL

T1D patients with blood collection

Procedure: Blood collection

Interventions

Blood collectionPROCEDURE

Ten cc of peripheral blood will be taken from patients and healthy controls as soon as possible after T1D diagnosis of the former.

Patients with diabetes

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, Midi-Pyrénées, 31059, France

Location

Related Publications (6)

  • Ferreira C, Singh Y, Furmanski AL, Wong FS, Garden OA, Dyson J. Non-obese diabetic mice select a low-diversity repertoire of natural regulatory T cells. Proc Natl Acad Sci U S A. 2009 May 19;106(20):8320-5. doi: 10.1073/pnas.0808493106. Epub 2009 Apr 9.

    PMID: 19359477BACKGROUND

  • Thiault N, Darrigues J, Adoue V, Gros M, Binet B, Perals C, Leobon B, Fazilleau N, Joffre OP, Robey EA, van Meerwijk JP, Romagnoli P. Peripheral regulatory T lymphocytes recirculating to the thymus suppress the development of their precursors. Nat Immunol. 2015 Jun;16(6):628-34. doi: 10.1038/ni.3150. Epub 2015 May 4.

    PMID: 25939024BACKGROUND

  • Steffens CM, Al-Harthi L, Shott S, Yogev R, Landay A. Evaluation of thymopoiesis using T cell receptor excision circles (TRECs): differential correlation between adult and pediatric TRECs and naive phenotypes. Clin Immunol. 2000 Nov;97(2):95-101. doi: 10.1006/clim.2000.4938.

    PMID: 11027449BACKGROUND

  • Calder AE, Hince MN, Dudakov JA, Chidgey AP, Boyd RL. Thymic involution: where endocrinology meets immunology. Neuroimmunomodulation. 2011;18(5):281-9. doi: 10.1159/000329496. Epub 2011 Sep 22.

    PMID: 21952680BACKGROUND

  • Sakaguchi S, Miyara M, Costantino CM, Hafler DA. FOXP3+ regulatory T cells in the human immune system. Nat Rev Immunol. 2010 Jul;10(7):490-500. doi: 10.1038/nri2785. Epub 2010 Jun 18.

    PMID: 20559327BACKGROUND

  • Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.

    PMID: 15189396BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Claire Le Tallec, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 2, 2017

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 1, 2020

Record last verified: 2020-03

Locations

FR(1)