RecruitingNCT06141434

PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life


Sponsor

University of Colorado, Denver

Enrollment

6,000 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

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 during pregnancy, such as having an infection, diet and growth may impact later risk of type 1 diabetes (TID) and islet autoimmunity in the child. We are also interested in finding out more about why having a father or sibling with T1D increases risk of autoimmunity in the child more than having a mother with T1D. We are enrolling women who are pregnant and either have T1D or another first degree relative (father or full sibling) of the baby has T1D. The biological father is also invited to enroll in study, as it is important to understand how the father's health and genetics may contribute to the child's risk of developing T1D. The study procedures for the mother, father and baby are explained below. Mother: Pregnant women will be asked to complete a visit once per trimester (3 visits) during pregnancy and one visit up to 12 weeks after delivery. At each visit, mothers will consent to a blood draw, collection of biological samples and the completion of questionnaires. . Mothers who have T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data. Father: The (biological) father will be invited to enroll in a single visit. He will consent to a blood draw and completion of questionnaires. Fathers with T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data. Baby: The baby will have blood collected at birth to determine the genetic risk for T1D. Families will consent to the completion of questionnaires about growth, health and diet at 6, 12, 18 and 24 months of age and between 5-7 years of age, and to complete blood testing for islet autoantibodies at 24 months and between 5-7 years of age. For those children with a high genetic risk score, we will also collect blood for autoantibody testing at 6, 12, and 18 months of age.


Eligibility

Min Age: 0 DaysMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study — called PROMISE — is following pregnant women and their babies to understand how factors during pregnancy (like the mother's health, diet, and environment) relate to the baby's risk of developing early warning signs of type 1 diabetes (called islet autoantibodies). It focuses on families with a history of type 1 diabetes. **You may be eligible if...** - You are pregnant and 18 or older - You are both the gestational and biological mother - Your pregnancy is 24 weeks or less at the time of enrollment - Your baby has a first-degree relative (mother, biological father, or full sibling) with type 1 diabetes **You may NOT be eligible if...** - Parents do not agree to genetic testing of the baby - You are carrying more than one baby (multiple pregnancy) - Your pregnancy is past 24 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

University of Colorado

Aurora, Colorado, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Mt Sinai

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

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NCT06141434


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