BeAT1D: Benign Autoimmunity and Type 1 Diabetes

NCT05139784 | Recruiting

• 2 other identifiers: C20-612021-A01619-32
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 17

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Autoimmunity; Lymphocytes; Beta cells; Biomarkers

Outcome Measures

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.

  6 years

Secondary Outcomes (7)

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

  6 years

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

  6 years

• To define the phenotype of these lymphocytes.

  6 years

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

  6 years

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

  6 years

Study Arms (4)

Type 1 diabetes

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

Other: Biosampling

Other forms of diabetes or autoimmune endocrinopathy

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

Other: Biosampling

No diabetes

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.

Other: Biosampling

Lymphadenectomy planned at the occasion of an abdominal surgery

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

Other: Biosampling

Interventions

Biosampling OTHER

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

Lymphadenectomy planned at the occasion of an abdominal surgery; No diabetes; Other forms of diabetes or autoimmune endocrinopathy; Type 1 diabetes

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (17)

APHP Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

NOT YET RECRUITING

APHP Hôpital J. Verdier

Bondy, Île-de-France Region, 93140, France

NOT YET RECRUITING

APHP Hôpital L. Mourier

Colombes, Île-de-France Region, 92700, France

NOT YET RECRUITING

Hôpital Sud Francilien

Corbeil-Essonnes, Île-de-France Region, 91100, France

NOT YET RECRUITING

Hôpital Mignot - Service de Pédiatrie

Le Chesnay, Île-de-France Region, 78150, France

NOT YET RECRUITING

Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes

Le Chesnay, Île-de-France Region, 78150, France

NOT YET RECRUITING

APHP Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

NOT YET RECRUITING

APHP Hôpital Lariboisière

Paris, Île-de-France Region, 75010, France

NOT YET RECRUITING

APHP Hôpital Saint Antoine

Paris, Île-de-France Region, 75012, France

NOT YET RECRUITING

APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

Hôpital Pitié-Salpêtrière - Service de Diabétologie

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

APHP Hôpital Cochin - Service de Chirurgie

Paris, Île-de-France Region, 75014, France

NOT YET RECRUITING

APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique

Paris, Île-de-France Region, 75014, France

RECRUITING

APHP Hôpital Européen G. Pompidou

Paris, Île-de-France Region, 75015, France

NOT YET RECRUITING

APHP Hôpital Bichat

Paris, Île-de-France Region, 75018, France

NOT YET RECRUITING

APHP Hôpital R. Debré

Paris, Île-de-France Region, 75019, France

NOT YET RECRUITING

Hôpital René Dubos

Pontoise, Île-de-France Region, 95300, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stools, lymph nodes

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• Roberto Mallone, MD PhD

  INSERM U1016 Cochin Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Mallone, MD PhD

CONTACT

+33176535583; roberto.mallone@inserm.fr

Anna Jones

CONTACT

anna.jones@inserm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 1, 2021
• Study Start: October 24, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

FR (17)