NCT05139784 BeAT1D: Benign Autoimmunity and Type 1 Diabetes
| NCT ID | NCT05139784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,160 participants |
| Start Date | 2022-10-24 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,160 participants in total. It began in 2022-10-24 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Roberto Mallone, MD PhD
PRINCIPAL INVESTIGATOR
INSERM U1016 Cochin Institute
Frequently Asked Questions
Who can join the NCT05139784 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05139784 currently recruiting?
Yes, NCT05139784 is actively recruiting participants. Contact the research team at roberto.mallone@inserm.fr for enrollment information.
Where is the NCT05139784 trial being conducted?
This trial is being conducted at Bobigny, France, Bondy, France, Colombes, France, Corbeil-Essonnes, France and 11 additional locations.
Who is sponsoring the NCT05139784 clinical trial?
NCT05139784 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Roberto Mallone, MD PhD at INSERM U1016 Cochin Institute. The trial plans to enroll 1,160 participants.
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