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

Plain-language summary

This study aims to characterize the features of CD4 T cells in the immune system of children newly diagnosed with type 1 diabetes and of control individuals. It enrolls children aged 2 to 18 with newly diagnosed type 1 diabetes (per ISPAD criteria) or without diabetes. It is a study without a designated phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Intervention

Frequency of Treg and Teffs, Phenotype of Treg and Teffs, RNA seq analysis, HLA typing, beta-cell autoantibody dosage, Glycated haemoglobin (HbA1C) dosage, blood glucose dosage, C-peptide dosage

Start date

5/6/2025

Estimated completion

5/1/2027

Countries

France

Related genes

Locations

• Paris, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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