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Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals

RecruitingNAAges 6 Years - 18 YearsAllAssistance Publique - Hôpitaux de Paris
NCT06427421 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Type 1 diabetes (T1D) is caused by an autoimmune response leading to the destruction of pancreatic beta cells. The disease association with particular HLA class II alleles, particularly HLA-DQ8, indicates the implication of CD4 T cells in its aetiology. The hypothesis is therefore that T1D starts by the loss of tolerance in autoreactive CD4 T cells. This might result from alterations in conventional autoreactive CD4 T cells (Tcons), which drive disease, or autoreactive regulatory CD4 T cells expressing the transcription factor FOXP3 (Tregs), which normally maintain immune tolerance. The investigators expect that the characterization of HLA-DQ8-restricted Tcons and Tregs in recent onset HLA-DQ8+ T1D patients shall shed light on the molecular mechanisms underpinning T1D development. This knowledge will guide the development of novel cell therapies harnessing the power of genetically engine

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📋 Eligibility rules (as published)
Inclusion Criteria: Newly diagnosed T1DM group: * Age ≥ 2 years and \< 18 years on day of inclusion; * Weight ≥ 12 kg; * Newly diagnosed T1DM, diagnosis defined according to International Society of Pediatric and Adolescent Diabetes (ISPAD) criteria by: hyperglycemia \> 2g/L and/or ketonemia and/or polyuro-polydipsia and/or weight loss ; * Absence of other associated inflammatory or autoimmune diseases; * Affiliation with a health insurance scheme or beneficiary (excluding AME); * Written consent of parental guardians; * Ability to understand and read French. Control group : * Age ≥ 2 years and \< 18 years on the day of inclusion; * Weight ≥ 12 kg; * No personal history of T1DM; * Affiliation with a health insurance scheme or entitled person (excluding AME); * Written consent from parental guardians; * Ability to understand and read French. Exclusion Criteria: Newly diagnosed T1DM group: * Use of oral or intravenous corticosteriods in the month prior to blood sampling * Contraindication to the use of anaesthetic cream for blood sampling. Control group : * History of autoimmune or inflammatory disease * Use of oral or intravenous corticosteriods in the month prior to blood sampling * Contraindication to the use of anaesthetic cream for blood sampling
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What it tests

  • Frequency of Treg and Teffs
  • Phenotype of Treg and Teffs
  • RNA seq analysis
  • HLA typing
  • beta-cell autoantibody dosage
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Where

1 site
Hôpital Necker Enfants Malades
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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