Clinical Trials in France / NCT05139784
Recruiting
Observational
BeAT1D: Benign Autoimmunity and Type 1 Diabetes
NCT05139784 · tracked via the Priya Life Science France tracker
Condition(s) studied
Type 1 Diabetes
Investigational drug(s) / intervention(s)
Biosampling
Biosampling: Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.
Study 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.
Eligibility
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 outcome measure(s)
- To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups. — 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.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| APHP Hôpital Avicenne | Bobigny | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital J. Verdier | Bondy | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital L. Mourier | Colombes | Île-de-France Region | Not Yet Recruiting |
| Hôpital Sud Francilien | Corbeil-Essonnes | Île-de-France Region | Not Yet Recruiting |
| Hôpital Mignot - Service de Pédiatrie | Le Chesnay | Île-de-France Region | Not Yet Recruiting |
| Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes | Le Chesnay | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Kremlin-Bicêtre | Le Kremlin-Bicêtre | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Lariboisière | Paris | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Saint Antoine | Paris | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie | Paris | Île-de-France Region | Not Yet Recruiting |
| Hôpital Pitié-Salpêtrière - Service de Diabétologie | Paris | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Cochin - Service de Chirurgie | Paris | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique | Paris | Île-de-France Region | Recruiting |
| APHP Hôpital Européen G. Pompidou | Paris | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital Bichat | Paris | Île-de-France Region | Not Yet Recruiting |
| APHP Hôpital R. Debré | Paris | Île-de-France Region | Not Yet Recruiting |
| Hôpital René Dubos | Pontoise | Île-de-France Region | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05139784 on ClinicalTrials.gov ↗ ← All trials in France