TRIGR is an international randomized clinical trial that examines the development of type 1 diabetes mellitus (T1DM) in genetically susceptible children. T1DM has been called an autoimmune disease because the body’s own immune system destroys the insulin-producing cells of the pancreas. Some studies have implicated foreign milk proteins from baby formulas as the initial targets of the immune response that later destroys the insulin-producing cells.
Traditional baby formulas, often produced from cow’s milk, contain complex milk proteins that can elicit an immune response. Breast milk and hydrolyzed milk formulas do not cause a similar immune response. In TRIGR, researchers are examining whether weaning infants from breast milk to a hydrolyzed formula lowers their risk of developing T1DM.
To date, TRIGR has enrolled 2,160 children who are genetically susceptible to T1DM on the basis of having first-degree relatives with T1DM. The health status of the children will be followed until they are 10 years old. The study will be completed in 2017, the year that the last child recruited turns 10 years old.
The Trial is funded by several NIH Institutes and other agencies, including the NICHD Pediatric Growth and Nutrition Branch (PGNB) (formerly the Endocrinology, Nutrition, and Growth (ENG) Branch), the National Institute of Diabetes and Digestive and Kidney Diseases, the Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation International, and the European Commission. NIH funding is provided through a Cooperative Agreement award mechanism (U01). Currently, 77 sites across 15 countries are participating in the trial.
TRIGR will examine whether weaning to the hydrolyzed formula, rather than a more traditional formula, leads to the following:
- Reduction in the cumulative incidence of diabetes-predictive auto-antibodies and/or clinical T1DM during the first 6 years of life
- Reduction in the cumulative incidence of T1DM in study participants by age 10
Currently, 77 sites in the following countries are participating:
- Czech Republic
- United States
A full list of participating centers is available through the TRIGR website.