RecruitingNCT05139784
BeAT1D: Benign Autoimmunity and Type 1 Diabetes
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
740 participants
Start Date
Oct 24, 2022
Study Type
OBSERVATIONAL
Conditions
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 diabetes.
Eligibility
Min Age: 1 Year
Inclusion Criteria4
- 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 Criteria1
- 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.
Interventions
OTHERBiosampling
Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT05139784
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