Status:
COMPLETED
T1D Risk Assessment in Kids With Relatives
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France
INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born...
Detailed Description
The prevalence of type 1 diabetes (T1D) is estimated between 0.2 and 0.4% in France. The incidence in France is more than 10/105 per year, with a steady increase (\~4%/year), especially in children. I...
Eligibility Criteria
Inclusion
- Mother and/or father with type 1 diabetes
- age \> 18 years
- type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
- planning to give birth or having given birth since less than 8 months
- agreeing to participate upon written informed consent
- covered by the French social security system
- Mother/father without Type 1 diabetes
- age \> 18 years old
- with a spouse with type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
- planning to give birth or having given birth since less than 8 months
- agreeing to participate upon written informed consent
- covered by the French social security system
- Children born to mother and/or father with type 1 diabetes
- age \< 8 months
- with at least one parent with T1D
- with both parents agreeing to participate
- both parents covered by the French social security system
Exclusion
- 1\) Mother/father
- secondary forms of diabetes
- monogenic forms of diabetes
- 1 or 2) For the mother
- malignant neoplastic or psychiatric disease
- 3 ) Newborns of mother/father with type 1 diabetes
- Severe foetal disease
- Severe congenital malformation
- Congenital measles
Key Trial Info
Start Date :
May 28 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2019
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT02184676
Start Date
May 28 2015
End Date
May 17 2019
Last Update
December 11 2025
Active Locations (1)
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1
Cochin Hospital
Paris, France, 75014