Trial to Reduce IDDM in those at Genetic Risk (TRIGR)

Pregnant women who: have type 1 diabetes OR the father of this baby has type 1 diabetes OR a full sibling to this baby has type 1 diabetes.

This randomized, double blinded intervention study will compare the incidence of predictive autoantibodies and clinical diabetes in the two treatment groups. The intervention will compare a casein hydrolysate with a standard cow milk based formula. Breast feeding is encouraged and supported in this study. The baby would be fed the study formula only if mom decides to bottle feed, wean from breast feeding before 8 months of age, or supplements breast feeding with formula.

There has been a suggestion that the early introduction of formulas containing cow milk may be related to the early development of diabetes. The goal of the study is to compare the two study formulas to see if there is a difference in the development of type 1 diabetes.

A cord blood sample is obtained after the baby is born to determine if the baby will remain in the study. We are looking at the genes associated with the development of type 1 diabetes. We make all the arrangement to have the cord blood sample drawn. We work with the mother's doctor, the baby's doctor, and the hospital. Babies can be enrolled in the study up to seven days of age if they have not received any formula. We are able to obtain enough blood from the baby's heel to do the genetic testing. If the baby is eligible to remain in the study, arrangements are made to have the follow up blood samples needed for the study. Participants do not have to visit study site. All 50 states are covered by the 5 mainland sites.

It would depend on the study. Please contact a study coordinator (see "How can I learn more?") to determine if you are eligible to participate in this study.

Please contact the location nearest you.