CClinicalTrials.gg
WithdrawnNCT03236558TregDiabUpdated Apr 1, 2020

The Role of the Thymus in Type I Diabetes.

An interventional study of Blood collection in Type1 Diabetes, sponsored by University Hospital, Toulouse. Withdrawn at 1 site in France. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science

Why this study was withdrawn
lack of Financial support
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type1 Diabetes

Keywords

  • Type 1 diabetes
  • Juvenile diabetes
  • Immune-tolerance
  • Regulatory T lymphocyte
  • Treg
  • TCR
  • Repertoire
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

Browse Diabetes Mellitus studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • other immunopathology
  • treatment with any anti-inflammatory or immunosuppressive drugs
  • puberty
  • legal protection
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Patients with diabetes

    T1D patients with blood collection

    Procedure: Blood collection

Interventions

  • ProcedureBlood collection

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

06

What researchers measure

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.

    Time frame: Day 1

Secondary outcomes

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

    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.

    Time frame: Day 1

07

Study locations

1 site
  • CHU de Toulouse
    Toulouse, Midi-Pyrénées 31059, France
08

References and documents

Publications

  • 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. PubMed 19359477 ↗
  • 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. PubMed 25939024 ↗
  • 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. PubMed 11027449 ↗
  • 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. PubMed 21952680 ↗
  • 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. PubMed 20559327 ↗
  • 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. PubMed 15189396 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03236558
Lead sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France
Responsible party
Sponsor
First posted
Aug 2, 2017
Start date
Mar 2018 (estimated)
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Apr 1, 2020

Study contacts

Claire Le Tallec, MD
principal investigator · CHU Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion