Type 1 diabetes in children is a major health problem in Europe, and the incidence of the disease is increasing. The consequences and costs of Type 1 diabetes presenting in childhood are immense. Type 1 diabetes develops in genetically susceptible individuals, if one or several environmental factors lead to autoimmune destruction of the pancreatic beta-cells. Cow milk proteins are one of the main candidates among the environmental factors. The objective of the present proposal is to determine whether denial of nutritional cow milk proteins for at least the first 6 months of life reduces the incidence of Type 1 diabetes in children at increased genetic risk of developing the disease and/or the appearance of diabetes associated antibodies by the age of 6 years. The proposal is based on a pilot study in man indicating that it may be possible to modify spontaneous beta-cell autoimmunity by dietary intervention.
The overall objective of the project is to determine whether weaning to a casein hydrolysate (Nutramigen TM) during at least the first 6 months of life reduces the incidence of Type 1 diabetes in genetically susceptible children. An important study question is, whether casein hydrolysate effects are due to the avoidance of complex weaning diets such as cow's milk based formula. This question will be addressed by correlating cow's milk immune responses with autoimmune markers and with diabetes.
Within the time frames of the present application, the trial will answer specific questions:
- Specific Aim I: Will the intervention reduce the frequency of autoimmune markers of beta-cell destruction during the first 6 years of life in subjects with increased genetic risk for Type I diabetes?
- Specific Aim II: Are there relationships between cow's milk antibodies, a measure of cow's milk exposure, and autoimmunity to islet antigens?
We will recruit and identify newborn infants with an increased genetic risk for Type 1 diabetes (Milestone 1), implement a dietary intervention in infancy (Milestone 2) to attempt to decrease the incidence of the disease (Milestone 3), and collect blood samples at follow-up visits to measure the effect of the intervention on the appearance of immunological markers of Type 1 diabetes (Milestone 4).