Clinical trial Recruiting at 3 sites Observational Ages 0 Days to 99

Examining how pregnancy factors affect the risk of type 1 diabetes in children

Official title: PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life

Run by University of Colorado, Denver · NCT06141434 · Data updated 2026-11-12

This study is trying to see how different factors during pregnancy might affect the chances of children developing type 1 diabetes.

More Type 1 Diabetes trials

Quick facts

Study typeObservational
Ages0 Days to 99 Years
SexAll
Enrollment6000 (estimated)
SponsorUniversity of Colorado, Denver
Academic / other
Locations4 sites (Aurora, Colorado and 3 other locations)
StatusRecruiting
StartedDecember 1, 2022
Main results expectedNovember 30, 2032
Study endsNovember 30, 2032
Registry record updatedNovember 21, 2023
Trial IDNCT06141434 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include pregnant women aged 18 or older who have type 1 diabetes or a first-degree relative with the condition.

Probably not a fit

Patients with multiple pregnancies or those whose parents do not consent to genetic testing may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown success in understanding the genetic and environmental factors influencing type 1 diabetes, making this approach both relevant and promising.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.