PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Massachusetts
Joslin Diabetes Center
RECRUITING
Boston
New York
Mt Sinai
RECRUITING
New York
Ohio
Ohio State University
NOT_YET_RECRUITING
Columbus
Contact Information
Primary
JANET K SNELL-BERGEON, PhD, MPH
Janet.Snell-Bergeon@cuanschutz.edu
7208917122
Backup
Catherine Chartier-Logan, MPH
Catherine.Chartier-Logan@cuanschutz.edu
3037247505
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2032-11-30
Participants
Target number of participants: 6000
Treatments
Pregnancies where the mother has type 1 diabetes
We will observe the risk for islet autoimmunity in the offspring where the mother has type 1 diabetes. There is no intervention in this study.
Pregnancies where the mother does not have type 1 diabetes
We will observe the risk for islet autoimmunity in the offspring where the mother does not have type 1 diabetes, but the baby's father or full sibling does. There is no intervention in this study.
Related Therapeutic Areas
Sponsors
Collaborators: Icahn School of Medicine at Mount Sinai, Joslin Diabetes Center, Ohio State University
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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