Status:
RECRUITING
BeAT1D: Benign Autoimmunity and Type 1 Diabetes
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
1+ years
Brief Summary
National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabet...
Detailed Description
The overall objective of this study is to define the differential characteristics of autoimmune T and B lymphocytes across individuals with T1D, other forms of diabetes or autoimmunity, and no disease...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
- 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
- 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.
Key Trial Info
Start Date :
October 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT05139784
Start Date
October 24 2022
End Date
December 1 2027
Last Update
May 16 2025
Active Locations (17)
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1
APHP Hôpital Avicenne
Bobigny, Île-de-France Region, France, 93000
2
APHP Hôpital J. Verdier
Bondy, Île-de-France Region, France, 93140
3
APHP Hôpital L. Mourier
Colombes, Île-de-France Region, France, 92700
4
Hôpital Sud Francilien
Corbeil-Essonnes, Île-de-France Region, France, 91100