Clinical trial NCT05139784: BeAT1D: Benign Autoimmunity and Type 1 Diabetes
Official title: BeAT1D: Benign Autoimmunity and Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Autoimmunity
Lymphocytes
Beta cells
Biomarkers
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2021-12-01
Enrollment: 740
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with type 1 diabetes, other forms of diabetes or autoimmune endocrinopathies and participants undergoing surgical lymphadenectomy are recruited among patients referred to participating hospital centers.

Non-diabetic participants are recruited among patient's family members and via at-large calls for healthy volunteers.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups.
timeFrame: 6 years
Secondary outcomes:
measure: To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups.
timeFrame: 6 years
measure: To identify novel islet epitopes recognized by autoimmune T and B lymphocytes.
timeFrame: 6 years
measure: To define the phenotype of these lymphocytes.
timeFrame: 6 years
measure: To define the pathogenicity of these lymphocytes against pancreatic beta cells.
timeFrame: 6 years
measure: To define the antigen receptors used by these lymphocytes to recognize their target epitopes.
timeFrame: 6 years
measure: To define the correlation between the biomarkers analyzed and insulin secretion.
timeFrame: 6 years
measure: To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes.
timeFrame: 6 years
Other outcomes:
Locations:
city: Bobigny
country: France
facility: APHP Hôpital Avicenne
state: Ile-de-France
city: Bondy
country: France
facility: APHP Hôpital J. Verdier
state: Ile-de-France
city: Colombes
country: France
facility: APHP Hôpital L. Mourier
state: Ile-de-France
city: Corbeil-Essonnes
country: France
facility: Hôpital Sud Francilien
state: Ile-de-France
city: Le Chesnay
country: France
facility: Hôpital Mignot - Service de Pédiatrie
state: Ile-de-France
city: Le Chesnay
country: France
facility: Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes
state: Ile-de-France
city: Le Kremlin-Bicêtre
country: France
facility: APHP Hôpital Kremlin-Bicêtre
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Lariboisière
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Saint Antoine
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière - Service de Diabétologie
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Cochin - Service de Chirurgie
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Européen G. Pompidou
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital Bichat
state: Ile-de-France
city: Paris
country: France
facility: APHP Hôpital R. Debré
state: Ile-de-France
city: Pontoise
country: France
facility: Hôpital René Dubos
state: Ile-de-France
Study officials:
affiliation: INSERM U1016 Cochin Institute
name: Roberto Mallone, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: