Characterizing autoimmune lymphocytes in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect biological samples from individuals with type 1 diabetes, other forms of diabetes, and healthy controls to analyze the characteristics of autoimmune T and B lymphocytes. By comparing these immune cells across different groups, the study seeks to clarify the mechanisms behind type 1 diabetes and identify potential biomarkers for diagnosis and treatment. The research is conducted across multiple centers in France, focusing on non-interventional biosampling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Type 1 diabetes: type 1 diabetes, as defined by hyperglycemia and long-term insulin therapy started within 6 months from clinical onset; and/or the presence of at least one anti-islet auto-antibody.
2. Other forms of diabetes or autoimmune endocrinopathy: other forms of diabetes (e.g. type 2, ketosis-prone, familial, secondary, immunotherapy-induced diabetes); and/or other autoimmune endocrinopathies, isolated or multiple.
3. No diabetes: absence of diabetes or impaired glucose tolerance; absence of tumor, infectious or immune pathologies, or other conditions related to autoimmune or metabolic alterations that may bias the variables under study.
4. Lymphadenectomy planned in the frame of an abdominal surgery: pancreatic lymphadenectomy planned at the occasion of an abdominal surgery for the treatment of an underlying condition.

Exclusion Criteria:

For all participants: ongoing pregnancy; known HIV/HCV infection; absence of social security coverage; placement under judicial protection; absence of signature of the informed study consent.

Where it's running

• APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique
  Paris, Île-de-France Region, France Recruiting
• APHP Hôpital Avicenne
  Bobigny, Île-de-France Region, France Not yet recruiting
• APHP Hôpital J. Verdier
  Bondy, Île-de-France Region, France Not yet recruiting
• APHP Hôpital L. Mourier
  Colombes, Île-de-France Region, France Not yet recruiting
• Hôpital Sud Francilien
  Corbeil-Essonnes, Île-de-France Region, France Not yet recruiting
• Hôpital Mignot - Service de Pédiatrie
  Le Chesnay, Île-de-France Region, France Not yet recruiting

Study contacts

• Principal investigator: Roberto Mallone, MD PhD — INSERM U1016 Cochin Institute
• Study coordinator: Roberto Mallone, MD PhD
• Email: roberto.mallone@inserm.fr
• Phone: +33176535583

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.