Condition: Type 1 Diabetes · Pregnancy in Diabetic · Sponsor: University of Colorado, Denver
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 al…
This description comes directly from the study's public registry record.
JANET K SNELL-BERGEON, PhD, MPH · 7208917122 · Janet.Snell-Bergeon@cuanschutz.edu
Catherine Chartier-Logan, MPH · 3037247505 · Catherine.Chartier-Logan@cuanschutz.edu
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06141434