Hydrolyzed Formula: No Drop in Risk for β-Cell Autoimmunity

Jennifer Garcia

June 17, 2014

Use of a hydrolyzed infant formula does not reduce the risk of developing diabetes-associated autoantibodies among infants at risk for type 1 diabetes, according to a study published in the June 11 issue of JAMA.

Researchers led by Mikael Knip, MD, DMSc, from the University of Helsinki, Finland, prospectively enrolled 2159 infants between May 2002 and January 2007 who had a first-degree relative with type 1 diabetes and a human leukocyte antigen (HLA) genotype suggestive of an increased risk for diabetes. The researchers randomly assigned the infants to receive either a hydrolyzed casein infant formula (n = 1078) or a conventional cows' milk-based formula (n = 1081) and monitored the babies for the development of islet cell antibodies and autoantibodies to insulin, glutamic acid decarboxylase, and insulinoma-associated-2(IA-s) molecule. The intervention lasted until infants were at least 6 months of age; infants in both groups were fed formula for a minimum of 60 days.

At the end of a median 7-year follow-up, the researchers found that 139 children in the hydrolyzed formula group (13.4%; 95% confidence interval [CI], 11.3% - 15.5%) were positive for 2 or more autoantibodies compared with 117 children in the control group (11.3%; 95% CI, 9.4% - 13.2%). Autoantibodies were detected as early as 3 months and as late as 9 years (to date).

Despite positive results from a smaller pilot study, "[t]his study showed that in this large international trial in children with an HLA genotype conferring increased risk for type 1 diabetes and an affected first-degree relative, weaning to a highly hydrolyzed formula during infancy was not associated with any reduction in the signs of cumulative β-cell autoimmunity," write Dr. Knip and colleagues.

The researchers acknowledge study limitations such as selection of infants with an increased risk of developing diabetes, so data may not be generalizable to all infant populations. In addition, it is unclear what, if any, effect breast-feeding may have had on the development of β-cell autoimmunity.

The study authors note that although use of hydrolyzed formula may affect "the degree and rate of progression of autoimmunity to clinical diabetes in high-risk children," longer-term follow-up of this cohort will be required and is planned.

Funding for this study was provided by the National Institute of Child Health and Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation International, Commission of the European Communities, European Foundation for the Study of Diabetes/Juvenile Diabetes Research Foundation/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation, and Finnish Diabetes Research Foundation. The authors have disclosed no relevant financial relationships.

JAMA. 2014;311:2279-2287. Abstract


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