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NCT Number: NCT05139784

BeAT1D: Benign Autoimmunity and Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP Hôpital Avicenne, Bobigny, Île-de-France Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Biosampling

Other

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

Primary outcomes

  1. To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups.

    Time frame: 6 years

    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.

Secondary outcomes

  1. To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups.

    Time frame: 6 years

    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.

  2. To identify novel islet epitopes recognized by autoimmune T and B lymphocytes.

    Time frame: 6 years

    As measured by a lymphocyte frequency within the expected range, e.g. 1-50/million.

  3. To define the phenotype of these lymphocytes.

    Time frame: 6 years

    As defined by exploratory analyses based on omics techniques.

  4. To define the pathogenicity of these lymphocytes against pancreatic beta cells.

    Time frame: 6 years

    As measured by an in vitro killing of beta-cell targets significantly (e.g. >2-fold) higher than the killing observed with control lymphocytes.

  5. To define the antigen receptors used by these lymphocytes to recognize their target epitopes.

    Time frame: 6 years

    As defined by sequencing techniques and sequence annotation using IMGT and MiXCR. Sequence sharing and similarities across receptors will be measured using MiXCR and stringdist.

  6. To define the correlation between the biomarkers analyzed and insulin secretion.

    Time frame: 6 years

    As measured based on the correlation with fasting C-peptide levels >0.2 nM.

  7. To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes.

    Time frame: 6 years

    As measured using the previous frequency and phenotype readouts.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Jones

CONTACT

[email protected]

Roberto Mallone, MD PhD

CONTACT

[email protected]

+33176535583

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Acronym: BeAT1D

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Dec 1, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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