RecruitingNot ApplicableNCT06427421

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

80 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how the immune system behaves in children who have just been diagnosed with Type 1 diabetes. Researchers will collect blood samples to study specific immune cells that may play a role in causing or controlling the disease. **You may be eligible if...** - Your child is between 2 and 18 years old - Your child weighs at least 12 kg - Your child was recently diagnosed with Type 1 diabetes (for the patient group), OR your child has no history of Type 1 diabetes (for the healthy comparison group) - Your family is affiliated with a French health insurance scheme - Parent or guardian consent is provided - Your child can understand and read French **You may NOT be eligible if...** - Your child (with Type 1 diabetes) has another inflammatory or autoimmune disease as well - Your child received oral or IV steroids in the month before the blood draw - Your child has a condition that prevents the use of numbing cream for blood collection - Your child (in the healthy group) has a personal history of any autoimmune or inflammatory disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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