Status:
RECRUITING
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Joslin Diabetes Center
Ohio State University
Conditions:
Type 1 Diabetes
Pregnancy in Diabetic
Eligibility:
All Genders
Up to 99 years
Brief Summary
This research study is called 'PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life: The PROMISE Study'. The purpose of this study is to find out more about how exposures d...
Detailed Description
We will assemble a prenatal cohort where the offspring has a first degree relative (FDR) with T1D (mother, father or full sibling). In order to enroll sufficient participants, we are conducting a mult...
Eligibility Criteria
Inclusion
- Pregnant women and their offspring where the offspring has a first degree relative (mother, biological father, full sibling) with type 1 diabetes
- Mother is 18 or older
- Mother is both gestational and biological mother
- Gestation up to 24 weeks at enrollment
Exclusion
- Parents do not agree to inclusion of the offspring in the study and genetic risk testing
- Greater than singleton pregnancy
Key Trial Info
Start Date :
December 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2032
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT06141434
Start Date
December 1 2022
End Date
November 30 2032
Last Update
November 21 2023
Active Locations (4)
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1
University of Colorado
Aurora, Colorado, United States, 80045
2
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
3
Mt Sinai
New York, New York, United States, 10029
4
Ohio State University
Columbus, Ohio, United States, 43081