BeAT1D: Benign Autoimmunity and Type 1 Diabetes

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Biosampling
  Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.

Первичные конечные точки

• To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups. [Срок оценки: 6 years]

Вторичные конечные точки (7)

• To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups. [Срок оценки: 6 years]
• To identify novel islet epitopes recognized by autoimmune T and B lymphocytes. [Срок оценки: 6 years]
• To define the phenotype of these lymphocytes. [Срок оценки: 6 years]
• To define the pathogenicity of these lymphocytes against pancreatic beta cells. [Срок оценки: 6 years]
• To define the antigen receptors used by these lymphocytes to recognize their target epitopes. [Срок оценки: 6 years]
• To define the correlation between the biomarkers analyzed and insulin secretion. [Срок оценки: 6 years]
• To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes. [Срок оценки: 6 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 17 центров

• 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
• … и ещё 9 центров

Идентификаторы

NCT: NCT05139784 · C20-61 · 2021-A01619-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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