BeAT1D: Benign Autoimmunity and Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biosampling.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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. The hypothesis is that the characterization of the autoimmune T and B lymphocytes involved in T1D development may allow us to clarify the pathophysiological mechanisms of disease and to identify novel biomarkers for diagnostic, prognostic and therapeutic follow-up applications.
Interventions
- Other Biosampling
Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.
Primary outcome measures
- To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups. [Time frame: 6 years]
Secondary outcome measures (7)
- To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups. [Time frame: 6 years]
- To identify novel islet epitopes recognized by autoimmune T and B lymphocytes. [Time frame: 6 years]
- To define the phenotype of these lymphocytes. [Time frame: 6 years]
- To define the pathogenicity of these lymphocytes against pancreatic beta cells. [Time frame: 6 years]
- To define the antigen receptors used by these lymphocytes to recognize their target epitopes. [Time frame: 6 years]
- To define the correlation between the biomarkers analyzed and insulin secretion. [Time frame: 6 years]
- To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes. [Time frame: 6 years]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 17 centers
- APHP Hôpital Avicenne — Bobigny
- APHP Hôpital J. Verdier — Bondy
- APHP Hôpital L. Mourier — Colombes
- Hôpital Sud Francilien — Corbeil-Essonnes
- Hôpital Mignot - Service de Pédiatrie — Le Chesnay
- Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes — Le Chesnay
- APHP Hôpital Kremlin-Bicêtre — Le Kremlin-Bicêtre
- APHP Hôpital Lariboisière — Paris
- … and 9 more centers
Identifiers
NCT: NCT05139784 · C20-61 · 2021-A01619-32