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Dietary intervention in infancy and later signs of beta-cell autoimmunity.

Abstract

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. (ClinicalTrials.gov number, NCT00570102.).

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  • Authors+Show Affiliations

    ,

    Hospital for Children and Adolescents, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland. mikael.knip@helsinki.fi

    , , , , , , , , , , , ,

    Source

    The New England journal of medicine 363:20 2010 Nov 11 pg 1900-8

    MeSH

    Animals
    Autoantibodies
    Autoimmunity
    Biomarkers
    Caseins
    Child
    Diabetes Mellitus, Type 1
    Disease Progression
    Double-Blind Method
    Genetic Predisposition to Disease
    Histocompatibility Testing
    Humans
    Infant
    Infant Formula
    Infant, Newborn
    Insulin-Secreting Cells
    Milk
    Milk, Human
    Pilot Projects

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21067382

    Citation

    Knip, Mikael, et al. "Dietary Intervention in Infancy and Later Signs of Beta-cell Autoimmunity." The New England Journal of Medicine, vol. 363, no. 20, 2010, pp. 1900-8.
    Knip M, Virtanen SM, Seppä K, et al. Dietary intervention in infancy and later signs of beta-cell autoimmunity. N Engl J Med. 2010;363(20):1900-8.
    Knip, M., Virtanen, S. M., Seppä, K., Ilonen, J., Savilahti, E., Vaarala, O., ... Akerblom, H. K. (2010). Dietary intervention in infancy and later signs of beta-cell autoimmunity. The New England Journal of Medicine, 363(20), pp. 1900-8. doi:10.1056/NEJMoa1004809.
    Knip M, et al. Dietary Intervention in Infancy and Later Signs of Beta-cell Autoimmunity. N Engl J Med. 2010 Nov 11;363(20):1900-8. PubMed PMID: 21067382.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Dietary intervention in infancy and later signs of beta-cell autoimmunity. AU - Knip,Mikael, AU - Virtanen,Suvi M, AU - Seppä,Karri, AU - Ilonen,Jorma, AU - Savilahti,Erkki, AU - Vaarala,Outi, AU - Reunanen,Antti, AU - Teramo,Kari, AU - Hämäläinen,Anu-Maaria, AU - Paronen,Johanna, AU - Dosch,Hans-Michael, AU - Hakulinen,Timo, AU - Akerblom,Hans K, AU - ,, PY - 2010/11/12/entrez PY - 2010/11/12/pubmed PY - 2010/12/14/medline SP - 1900 EP - 8 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 363 IS - 20 N2 - 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. (ClinicalTrials.gov number, NCT00570102.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/21067382/Dietary_intervention_in_infancy_and_later_signs_of_beta_cell_autoimmunity_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa1004809?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -