Characterizing autoimmune lymphocytes in type 1 diabetes
BeAT1D: Benign Autoimmunity and Type 1 Diabetes
This study is trying to understand the immune cells involved in type 1 diabetes by collecting samples from people with type 1 diabetes, other types of diabetes, and healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 740 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Drugs / interventions | immunotherapy |
| Locations | 17 sites (Bobigny, Île-de-France Region and 16 other locations) |
| Trial ID | NCT05139784 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 1 diabetes, other types of diabetes, or healthy individuals without any autoimmune or metabolic disorders.
Not a fit: Patients with ongoing pregnancy or known HIV/HCV infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for type 1 diabetes.
How similar studies have performed: Other studies have shown promise in characterizing autoimmune responses in diabetes, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bobigny, Île-de-France Region and 16 other locations
- 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)
- Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes — Le Chesnay, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Kremlin-Bicêtre — Le Kremlin-Bicêtre, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Lariboisière — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Saint Antoine — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie — Paris, Île-de-France Region, France (Not_yet_recruiting)
- Hôpital Pitié-Salpêtrière - Service de Diabétologie — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Cochin - Service de Chirurgie — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique — Paris, Île-de-France Region, France (Recruiting)
- APHP Hôpital Européen G. Pompidou — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital Bichat — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Hôpital R. Debré — Paris, Île-de-France Region, France (Not_yet_recruiting)
- Hôpital René Dubos — Pontoise, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.