Actively Recruiting
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
Led by University of Colorado, Denver · Updated on 2023-11-21
6000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
J
Joslin Diabetes Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how exposures during pregnancy, such as infections, diet, and growth, may affect a child's risk of developing type 1 diabetes (T1D) and islet autoimmunity. This study focuses on families where the baby has a first degree relative with T1D, including mothers, fathers, or siblings, and aims to understand why risk varies depending on which family member has T1D. The study is observational and involves multiple research centers in the United States. Pregnant women with T1D or whose baby has a father or sibling with T1D are enrolled along with the biological fathers. Mothers have visits once per trimester and up to 12 weeks after delivery, with blood draws, biological sample collections, and questionnaires. Fathers have a single visit with blood collection and questionnaires. Babies have blood collected at birth for genetic risk testing and are followed with questionnaires and blood tests for autoantibodies at several ages up to 7 years. Participants provide medical records, complete questionnaires on health, diet, and diabetes management, and provide biological samples including blood, vaginal swabs, stool, and cord blood. The study measures islet autoantibody development in children up to six years old and monitors glycemic control in mothers with T1D. Families receive education on T1D signs and symptoms and may access support programs. The study follows children at high genetic risk more closely with additional blood testing and questionnaires.
CONDITIONS
Brief Title
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 years or older
- Mother is both gestational and biological mother
- Gestation up to 24 weeks at enrollment
You will not qualify if you...
- Parents do not agree to inclusion of the offspring in the study and genetic risk testing
- Greater than singleton pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks gestation at enrollment
Participants provide medical history and complete questionnaires online to gather prenatal and family health information.
1 visit (in-person or remote) for fathers; up to 4 visits for mothers during pregnancy and postpartum
Duration - From enrollment through 12 weeks postpartum
Participants' medical records and samples are collected during pregnancy and up to 12 weeks postpartum to observe maternal and infant health, including blood samples, questionnaires, and specimen collections.
4 visits for mothers (first, second, third trimester, and postpartum); 1 visit for fathers; additional sample collections at birth
Duration - Up to 6 years of age
Offspring are monitored for islet autoantibodies and health outcomes through regular blood tests and questionnaires up to six years of age to assess risk for type 1 diabetes.
Blood collection every 6 months through 2 years for high-risk infants; blood collection at 2 years and 5-6 years for low-risk infants
Trial Site Locations
Total: 4 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Mt Sinai
New York, New York, United States, 10029
Actively Recruiting
4
Ohio State University
Columbus, Ohio, United States, 43081
Not Yet Recruiting
Research Team
J
JANET K SNELL-BERGEON, PhD, MPH
C
Catherine Chartier-Logan, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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