PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life - The PROMISE Study
This study wants to learn more about how exposures during pregnancy like infections, diet and growth, can affect a baby’s chances of developing type 1 diabetes later in life.
Why this Research Matters
A baby’s health before birth may affect their chances of getting islet autoimmunity (IA), which can lead to type 1 diabetes (T1D) in the child. Illnesses like viruses and pregnancy history might play a role in IA and T1D risk. A child is less likely to develop T1D if their mother has it compared to if their father has it.
If you join this study, you will have study visits during the first, second, and third trimester of your pregnancy, and one visit after your baby is born. During your first, second, and third trimester visits, you will fill out surveys about your health. We will take a small amount of blood from your arm using an IV. We will also check your blood pressure, height, and weight. You can choose to provide a vaginal swab and stool sample. We will also ask for your permission to access your medical records. You will have one visit after you give birth. At this visit, you will fill out surveys, and we will check your blood pressure, height, and weight. We will also take a small amount of your blood. After your baby is born, you will collect a small amount of blood from the umbilical cord (where the doctor cut it) and send it to us. This will help us see if your baby is at risk for T1D.
You will have four in-person study visits at CU Anschutz Medical Campus- one in your first trimester, one in your second trimester, one in your third trimester, and one after your baby is born. If your baby is low risk for T1D, then you and your baby will have two study visits. The first visit will be at 2 years of age and the second visit will be between 5 and 7 years of age. If your baby is high risk for T1D, then you will have 5 study visits at 6 months, 1 year, 18 months, 2 years, and between 5-6 years of age. You and your child will be in the study for up to 6 years.
You may be able to join this study if you are pregnant and:
- Are 18 years or older.
- Are between 8 and 24 weeks along with one baby.
- Have had type 1 diabetes for at least 12 months, or the baby's father or a full sibling has type 1 diabetes.
You will be compensated $25 for each visit you complete.
