Actively Recruiting
Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
80
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For newly diagnosed Type 1 diabetes group: Age 2 to under 18 years on day of inclusion
- Weight at least 12 kg
- Newly diagnosed Type 1 diabetes defined by ISPAD criteria (high blood sugar > 2g/L and/or ketonemia and/or excessive urination and thirst and/or weight loss)
- No other associated inflammatory or autoimmune diseases
- Affiliated with a health insurance scheme (excluding AME)
- Written consent from parental guardians
- Ability to understand and read French
- For control group: Age 2 to under 18 years on day of inclusion
- Weight at least 12 kg
- No personal history of Type 1 diabetes
- Affiliated with a health insurance scheme (excluding AME)
- Written consent from parental guardians
- Ability to understand and read French
You will not qualify if you...
- For newly diagnosed Type 1 diabetes group: Use of oral or intravenous corticosteroids in the month before blood sampling
- Contraindication to the use of anesthetic cream for blood sampling
- For control group: History of autoimmune or inflammatory disease
- Use of oral or intravenous corticosteroids in the month before blood sampling
- Contraindication to the use of anesthetic cream for blood sampling
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
Research Team
J
Jacques BELTRAND, MD, PhD
CONTACT
S
Sarah BOUCHARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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