BeAT1D: Benign Autoimmunity and Type 1 Diabetes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Biosampling
Other interventionCollection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.
Treatment groups
1,160 Participants
are divided into 4 treatment groupsGroup A: Type 1 diabetes1 intervention
Group B: Other forms of diabetes or autoimmune endocrinopathy1 intervention
Group C: No diabetes1 intervention
Group D: Lymphadenectomy planned at the occasion of an abdominal surgery1 intervention
Trial outcomes
Primary outcomes
1
To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups.
As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk. Frequency will be expressed as number of antigen-reactive T lymphocytes per 100,000 total T lymphocytes (e.g. 20/100,000 or 0.02%). Phenotype will be expressed as percent of antigen-reactive T lymphocytes expressing a given phenotype, e.g. 20% naïve (CD45RA+CCR7+). These 2 measures will be aggregated by expressing the frequency of antigen-reactive T lymphocytes per 100,000 total T lymphocytes expressing a given phenotype, e.g. 20/100,000 antigen-reactive T lymphocytes with 20% naïve will be expressed as 4/100,000 naive antigen-reactive T lymphocytes.
Time frame
6 yearsSecondary outcomes
1
To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups.
As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk. Frequency will be expressed as number of antigen-reactive B lymphocytes per 100,000 total B lymphocytes (e.g. 20/100,000 or 0.02%). Phenotype will be expressed as percent of antigen-reactive B lymphocytes expressing a given phenotype, e.g. 20% memory (CD24+CD38-negative). These 2 measures will be aggregated by expressing the frequency of antigen-reactive B lymphocytes per 100,000 total B lymphocytes expressing a given phenotype, e.g. 20/100,000 antigen-reactive B lymphocytes with 20% memory will be expressed as 4/100,000 memory antigen-reactive B lymphocytes.
Time frame
6 years2
To identify novel islet epitopes recognized by autoimmune T and B lymphocytes.
As measured by a lymphocyte frequency within the expected range, e.g. 1-50/million.
Time frame
6 years3
To define the phenotype of these lymphocytes.
As defined by exploratory analyses based on omics techniques.
Time frame
6 years4
To define the pathogenicity of these lymphocytes against pancreatic beta cells.
As measured by an in vitro killing of beta-cell targets significantly (e.g. \>2-fold) higher than the killing observed with control lymphocytes.
Time frame
6 yearsSponsors and contacts
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Source ClinicalTrials.gov