PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
PROMISE
1 other identifier
observational
6,000
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2032
November 21, 2023
November 1, 2023
10 years
November 15, 2023
November 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Islet autoimmunity in the offspring
Positive autoantibodies in the offspring's blood samples
up to six years of age
Study Arms (2)
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.
Eligibility Criteria
The study population will consist of pregnant women with singleton pregancies at up to 24 weeks gestation at enrollment, where the offspring has a first degree relative (mother, biological father or full sibling) with type 1 diabetes. Participation of fathers in the study is optional, and consists of a single visit. The mother must consent to the participation of the offspring in the study, which consists of screening for genetic risk for type 1 diabetes and antibody testing during childhood, with the schedule based on genetic risk.
You may qualify if:
- 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
You may not qualify if:
- Greater than singleton pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Joslin Diabetes Centercollaborator
- Ohio State Universitycollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
Study Sites (4)
University of Colorado
Aurora, Colorado, 80045, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Mt Sinai
New York, New York, 10029, United States
Ohio State University
Columbus, Ohio, 43081, United States
Biospecimen
Specimens collected from mothers includes plasma, serum, DNA, and optional vaginal swabs and stool samples during pregnancy (once per trimester) and post-partum. Specimens collected from offspring include cord blood at birth, plasma, serum and DNA. Specimens collected from fathers includes plasma, serum and DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JANET K SNELL-BERGEON, PhD, MPH
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2023
First Posted
November 21, 2023
Study Start
December 1, 2022
Primary Completion (Estimated)
November 30, 2032
Study Completion (Estimated)
November 30, 2032
Last Updated
November 21, 2023
Record last verified: 2023-11