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Hydrolyzed formula did not reduce risk for diabetes
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The use of hydrolyzed formula did not reduce the incidence of diabetes-associated autoantibodies among infants at risk for type 1 diabetes, according to study findings in JAMA.
Mikael Knip, MD, DMSc, of the University of Helsinki, Finland, and colleagues randomly assigned infants at risk for type 1 diabetes to receive an extensively hydrolyzed casein-based formula (n=1,078) or a conventional cow’s milk-based formula (n=1,081) until they were at least aged 6 months or had received study formula for at least 60 days. The study was conducted in 78 centers in 15 countries. Blood samples were obtained at ages 3, 6, 9, 12, 18 and 24 months, and thereafter annually up to age 10 years.
During the follow-up period, 2,070 children (1,035 in each group) provided at least one blood sample for determination of diabetes-associated autoantibodies. An estimated 13% of children in the experimental group (n=139) and 11.3% of the control group (n=117) tested positive for two or more autoantibodies. At least one autoantibody developed in 431 children in the experimental group (41.6%; 95% CI, 38.6%-44.6%) and in 414 in the control group (40%; 95% CI, 37%-43%).
Overall, 136 of the 256 children with multiple autoantibodies (53.1%) had only one autoantibody in their first positive sample. Of these, insulin autoantibodies were the first to appear in 47 children (34.6%); glutamic acid decarboxylase antibodies in 46 children (33.8%); islet cell antibodies in 41 children (30.1%); and insulinoma-associated 2 molecule antibodies in two children (1.5%). There were no differences between the two study groups regarding which antibodies appeared first.
These study findings contrast data from the Trial to Reduce IDDM in the Genetically at Risk (TRIGR) pilot study, which indicated weaning infants to an extensively hydrolyzed formula was associated with an estimated 50% reduction in cumulative incidence of beta-cell autoimmunity by the age of 10 among children at risk for diabetes. The TRIGR study findings may be limited by its small cohort, which consisted of 230 Finnish children, according to researchers.
“Our experience shows that a large-scale primary preventive dietary intervention aimed at decreasing the risk of type 1 diabetes is feasible. In contrast to the pilot study and supportive animal and uncontrolled human studies, weaning to a hydrolyzed formula in early infancy had no effect on the development of beta-cell autoimmunity,” they concluded. “It is possible, however, that the hydrolyzed formula affects the degree and rate of progression of autoimmunity to clinical diabetes in high-risk children, which will be ascertained in the TRIGR cohort by the 10-year follow-up.”
Disclosure: The researchers report no relevant financial disclosures.
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