PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-99
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Parents do not agree to inclusion of the offspring in the study and genetic risk testing
Greater than singleton pregnancy
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6,000 Participants
are grouped into 2 trial groupsGroup A: Pregnancies where the mother has type 1 diabetes
Group B: Pregnancies where the mother does not have type 1 diabetes
Trial outcomes
Primary outcomes
1
Islet autoimmunity in the offspring
Positive autoantibodies in the offspring's blood samples
Time frame
up to six years of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Joslin Diabetes Center
Collaborator
Ohio State University
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov