NCT06427421 Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
| NCT ID | NCT06427421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-05-06 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 engineered Tregs expressing the relevant antigen receptor to restore immune homeostasis upon cell transfer. The ultimate goal is to reach a curative effect
Eligibility Criteria
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
Contact & Investigator
Simon FILATREAU, PhD
STUDY DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT06427421 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06427421 currently recruiting?
Yes, NCT06427421 is actively recruiting participants. Contact the research team at jacques.beltrand@aphp.fr for enrollment information.
Where is the NCT06427421 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06427421 clinical trial?
NCT06427421 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Simon FILATREAU, PhD at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.