Examining how pregnancy factors affect the risk of type 1 diabetes in children
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
University of Colorado, Denver · NCT06141434
This study is trying to see how different factors during pregnancy might affect the chances of children developing type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 0 Days to 99 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Trial ID | NCT06141434 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of prenatal and obstetric maternal exposures on the risk of type 1 diabetes and islet autoimmunity in children. It focuses on pregnant women who have type 1 diabetes or a first-degree relative with the condition, enrolling both mothers and biological fathers to assess genetic and health contributions. Participants will complete three visits during pregnancy to gather data on various exposures and their potential effects on the child's health. The study aims to recruit a total of 2,000 participants across multiple renowned medical centers.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 or older who have type 1 diabetes or a first-degree relative with the condition.
Not a fit: Patients with multiple pregnancies or those whose parents do not consent to genetic testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and prevention strategies for type 1 diabetes in children.
How similar studies have performed: Previous studies have shown success in understanding the genetic and environmental factors influencing type 1 diabetes, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Parents do not agree to inclusion of the offspring in the study and genetic risk testing * Greater than singleton pregnancy
Where this trial is running
Aurora, Colorado and 3 other locations
- University of Colorado — Aurora, Colorado, United States (RECRUITING)
- Joslin Diabetes Center — Boston, Massachusetts, United States (RECRUITING)
- Mt Sinai — New York, New York, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: JANET K SNELL-BERGEON, PhD, MPH — University of Colorado, Denver
- Study coordinator: JANET K SNELL-BERGEON, PhD, MPH
- Email: Janet.Snell-Bergeon@cuanschutz.edu
- Phone: 7208917122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Pregnancy in Diabetic