BeAT1D: Benign Autoimmunity and Type 1 Diabetes

Institut National de la Santé Et de la Recherche Médicale, France

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Other: Biosampling

Study type: Observational

Funder types: Other

Identifiers

NCT05139784

2021-A01619-32 (Other Identifier)

C20-61

Details and patient eligibility

About

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.

Full 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.

Enrollment: 740 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

740 participants in 4 patient groups

Type 1 diabetes

Description:

As defined by the presence of hyperglycemia and/or islet auto-antibodies.

Treatment:

Other: Biosampling

Other forms of diabetes or autoimmune endocrinopathy

Description:

Type 2 diabetes, ketosis-prone diabetes, familial diabetes, secondary diabetes, immunotherapy-induced diabetes; and/or autoimmune endocrinopathies.

Treatment:

Other: Biosampling

No diabetes

Description:

No diabetes or impaired glucose tolerance; no cancer, infectious or immune pathologies; no other condition related to autoimmune and metabolic alterations that may bias the variables under study.

Treatment:

Other: Biosampling

Lymphadenectomy planned at the occasion of an abdominal surgery

Description:

Patients undergoing a lymphadenectomy during surgery for the treatment of their underlying pathology.

Treatment:

Other: Biosampling