Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes,JAMA

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Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes
JAMA ( IF 63.1 ) Pub Date : 2018-01-02 , DOI: 10.1001/jama.2017.19826
, Mikael Knip _{1,

2} , Hans K. Åkerblom ₁ , Eva Al Taji ₃ , Dorothy Becker ₄ , Jan Bruining ₅ , Luis Castano ₆ , Thomas Danne ₇ , Carine de Beaufort ₈ , Hans-Michael Dosch ₉ , John Dupre ₁₀ , William D. Fraser ₁₁ , Neville Howard ₁₂ , Jorma Ilonen ₁₃ , Daniel Konrad ₁₄ , Olga Kordonouri ₇ , Jeffrey P. Krischer ₁₅ , Margaret L. Lawson ₁₆ , Johnny Ludvigsson ₁₇ , Laszlo Madacsy ₁₈ , Jeffrey L. Mahon ₁₀ , Anne Ormisson ₁₉ , Jerry P. Palmer ₂₀ , Paolo Pozzilli ₂₁ , Erkki Savilahti ₁ , Manuel Serrano-Rios ₂₂ , Marco Songini ₂₃ , Shayne Taback ₂₄ , Outi Vaarala _{1,

25} , Neil H. White ₂₆ , Suvi M. Virtanen ₂₇ , Renata Wasikowa ₂₈

Affiliation

University of Helsinki, Helsinki, Finland
Helsinki University Hospital, Helsinki, Finland
Charles University, 3rd Faculty of Medicine, Prague, Czech Republic
University of Pittsburgh, Pittsburgh, Pennsylvania
Sophia Children’s Hospital, Rotterdam, the Netherlands
Cruces University Hospital-UPV/EHU-CIBERDEM/CIBERER, Barakaldo, Spain
Kinder-und Jugendkrankenhaus Auf Der Bult, Hannover, Germany
Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg
University of Toronto, Toronto, Ontario, Canada
University of Western Ontario, London, Ontario, Canada
Université de Sherbrooke, Sherbrooke, Quebec, Canada
Children’s Hospital of Westmead, Sydney, Australia
University of Turku and Turku University Hospital, Turku, Finland
University Children’s Hospital Zürich, Zürich, Switzerland
University of South Florida, Tampa
Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Linköping University, Linköping, Sweden
Semmelweis Medical University, Budapest, Hungary
Tartu University, Tartu, Estonia
University of Washington, Seattle
University Campus Bio-Medico of Rome, Rome, Italy
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Madrid, Spain
St Michelle Hospital /Azienda Ospedaliera Brotzu-Diabetes Unit, Cagliari, Italy
University of Manitoba, Winnipeg, Manitoba, Canada
Respiratory, Inflammation and Autoimmunity, Innovative Medicine, AstraZeneca, Gothenburg, Sweden
Washington University School of Medicine, St Louis, Missouri
National Institute of Health and Welfare, Helsinki, Finland
Medical University of Wroclaw, Wroclaw, Poland

Importance Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. Objective To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. Design, Setting, and Participants An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen–conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. Interventions The participants received either a casein hydrolysate or a conventional adapted cow’s milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. Main Outcomes and Measures Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). Results Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8% [95% CI, −1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, −0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). Conclusions and Relevance Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes. Trial Registration clinicaltrials.gov Identifier: NCT00179777

中文翻译：

水解婴儿配方奶粉与传统配方奶粉对 1 型糖尿病风险的影响

重要性早期接触复杂的膳食蛋白质可能会增加具有遗传病易感性的儿童患 1 型糖尿病的风险。深度水解配方中没有完整的蛋白质。目的检验断奶至深度水解配方可降低幼儿 1 型糖尿病累积发病率的假设。设计、设置和参与者 2002 年 5 月至 2007 年 1 月在 15 个国家的 78 个研究中心招募了 2159 名患有人类白细胞抗原赋予疾病易感性的婴儿和 1 型糖尿病的一级亲属的国际双盲随机临床试验；1081 名被随机分配至完全水解酪蛋白配方奶粉，1078 名被随机分配至常规配方奶粉。参与者的随访于2017年2月28日结束。干预措施参与者接受酪蛋白水解物或添加了 20% 酪蛋白水解物的常规改良牛奶配方。研究配方暴露的最短持续时间为 6 至 8 个月大时 60 天。主要结果和措施主要结果是根据世界卫生组织标准诊断的 1 型糖尿病。次要结果包括糖尿病诊断时的年龄和安全性（不良事件）。结果在随机分配的 2159 名新生儿（1021 名女性 [47.3%]）中，1744 名（80.8%）完成了试验。参与者的观察中位数为 11.5 年（四分位数 [Q] 1-Q3，10.2-12.8）。随机分配至酪蛋白水解物的患者 (n = 91) 的 1 型糖尿病绝对风险为 8.4%，而随机分配至常规配方的患者 (n = 82) 的 1 型糖尿病绝对风险为 7.6%（差异，0.8% [95% CI，-1。6% 到 3.2%]）。根据人类白细胞抗原风险组、母乳喂养持续时间、研究配方消费持续时间、性别和地区调整后的 1 型糖尿病风险比为 1.1（95% CI，0.8 至 1.5；P = .46）。两组诊断 1 型糖尿病时的中位年龄相似（6.0 岁 [Q1-Q3，3.1-8.9] vs 5.8 岁 [Q1-Q3，2.6-9.1]；差异，0.2 岁 [95% CI，- 0.9 到 1.2]）。上呼吸道感染是最常见的不良事件报告（频率，水解物组为 0.48 次事件/年，对照组为 0.50 次事件/年）。结论和相关性在有 1 型糖尿病风险的婴儿中，在中位随访 11.5 年后，与传统配方奶粉相比，断奶至水解配方奶粉并未降低 1 型糖尿病的累积发病率。这些发现不支持修改对有 1 型糖尿病风险的婴儿的饮食建议的需要。试验注册clinicaltrials.gov 标识符：NCT00179777

更新日期：2018-01-02

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