期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 363, 期 20, 页码 1900-1908出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1004809
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资金
- Academy of Finland
- European Commission [BMH4-CT96-0233]
- Juvenile Diabetes Foundation International [195003]
- Helsinki University Central Hospital
- University of Helsinki
- Finnish Diabetes Research Foundation
- Novo Nordisk Foundation
- Medical Research Foundation of Tampere University Hospital
- Dorothea Olivia, Karl Walter, and Jarl Walter Perklen Foundation
- Liv och Halsa Fund
Background: Early exposure to complex dietary proteins may increase the risk of beta-cell autoimmunity and type 1 diabetes in children with genetic susceptibility. We tested the hypothesis that supplementing breast milk with highly hydrolyzed milk formula would decrease the cumulative incidence of diabetes-associated autoantibodies in such children. Methods: In this double-blind, randomized trial, we assigned 230 infants with HLA-conferred susceptibility to type 1 diabetes and at least one family member with type 1 diabetes to receive either a casein hydrolysate formula or a conventional, cow's-milk-based formula (control) whenever breast milk was not available during the first 6 to 8 months of life. Autoantibodies to insulin, glutamic acid decarboxylase (GAD), the insulinoma-associated 2 molecule (IA-2), and zinc transporter 8 were analyzed with the use of radiobinding assays, and islet-cell antibodies were analyzed with the use of immunofluorescence, during a median observation period of 10 years (mean, 7.5). The children were monitored for incident type 1 diabetes until they were 10 years of age. Results: The unadjusted hazard ratio for positivity for one or more autoantibodies in the casein hydrolysate group, as compared with the control group, was 0.54 (95% confidence interval [CI], 0.29 to 0.95), and the hazard ratio adjusted for an observed difference in the duration of exposure to the study formula was 0.51 (95% CI, 0.28 to 0.91). The unadjusted hazard ratio for positivity for two or more autoantibodies was 0.52 (95% CI, 0.21 to 1.17), and the adjusted hazard ratio was 0.47 (95% CI, 0.19 to 1.07). The rate of reported adverse events was similar in the two groups. Conclusions: Dietary intervention during infancy appears to have a long-lasting effect on markers of beta-cell autoimmunity -- markers that may reflect an autoimmune process leading to type 1 diabetes. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT00570102.) N Engl J Med 2010;363:1900-8.
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