RECRUITINGOBSERVATIONAL
BeAT1D: Benign Autoimmunity and Type 1 Diabetes
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Biosampling
Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.
Locations (17)
APHP Hôpital Avicenne
Bobigny, Île-de-France Region, France
APHP Hôpital J. Verdier
Bondy, Île-de-France Region, France
APHP Hôpital L. Mourier
Colombes, Île-de-France Region, France
Hôpital Sud Francilien
Corbeil-Essonnes, Île-de-France Region, France
Hôpital Mignot - Service de Pédiatrie
Le Chesnay, Île-de-France Region, France
Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes
Le Chesnay, Île-de-France Region, France
APHP Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France
APHP Hôpital Lariboisière
Paris, Île-de-France Region, France
APHP Hôpital Saint Antoine
Paris, Île-de-France Region, France
APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie
Paris, Île-de-France Region, France
Hôpital Pitié-Salpêtrière - Service de Diabétologie
Paris, Île-de-France Region, France
APHP Hôpital Cochin - Service de Chirurgie
Paris, Île-de-France Region, France
APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique
Paris, Île-de-France Region, France
APHP Hôpital Européen G. Pompidou
Paris, Île-de-France Region, France
APHP Hôpital Bichat
Paris, Île-de-France Region, France
APHP Hôpital R. Debré
Paris, Île-de-France Region, France
Hôpital René Dubos
Pontoise, Île-de-France Region, France