The PROMISE Study: Understanding Type 1 Diabetes Risk in Children

The PROMISE Study is an observational research study looking into how experiences during pregnancy, like infections, diet, and growth, might affect a child's risk of developing type 1 diabetes (T1D) and islet autoimmunity (when the body's immune system mistakenly attacks its own cells) later in life. We're also interested in why a child's risk of autoimmunity is higher when their father or a sibling has T1D, compared to when their mother has it. We are enrolling pregnant women where the baby's mother, father, or a full sibling has type 1 diabetes. The study will follow the children up to six years of age to see if they develop islet autoimmunity. This study does not involve any specific interventions or medications.

Study design
This is an observational study aiming to enroll 6000 participants. It is being conducted at multiple centers, including the Barbara Davis Center for Diabetes, Mt Sinai Hospital, Joslin Diabetes Center, and Ohio State University.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Children will be followed up to six years of age to measure islet autoimmunity.

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NCT06141434

PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life

Recruiting
Not specifiedAges 0–99Observational
University of Colorado, Denver
~6,000 participants
Updated 2023-11-21 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Islet autoimmunity in the offspring
Measured over up to six years of age
Type 1 Diabetes
Pregnancy in Diabetic
4 sites across 4 states
Colorado1
Massachusetts1
New York1
Ohio1
  • JANET K SNELL-BERGEON, PhD, MPH · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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Eligibility criteria

Inclusion

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

Exclusion

Parents do not agree to inclusion of the offspring in the study and genetic risk testing
Greater than singleton pregnancy
  • Islet autoimmunity in the offspringup to six years of age

    Positive autoantibodies in the offspring's blood samples