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Study shows that modified baby formula does not prevent type 1 diabetes in kids

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Question   Does weaning to an extensively hydrolyzed formula decrease the cumulative incidence of type 1 diabetes in children at risk?

Findings  In this randomized clinical trial that included 2159 children with human leukocyte antigen-conferred susceptibility to type 1 diabetes and at least 1 affected family member, weaning to a hydrolyzed formula compared with a conventional formula did not significantly decrease the cumulative incidence of type 1 diabetes after a median of 11.5 years (8.4% vs 7.6%).

Meaning   Weaning to a hydrolyzed formula did not reduce the risk of type 1 diabetes in children with an increased disease risk.

 

The long-awaited results from the first large international trial to try to prevent type 1 diabetes shows that modified baby formula in which cow's milk proteins have been split does not prevent type 1 diabetes in children with genetic risk factors for the condition, according to researchers at Children's Hospital of Pittsburgh of UPMC, the coordinating center for the U.S. arm of the study. The findings were published in the  Journal of the American Medical Association.

 

Previous studies have reported that early exposure to complex foreign proteins, such as cow's milk proteins, may  increase the risk of type 1 diabetes in young children with genetic risk for type 1 diabetes.

 

In 2002, the research team for TRIGR (Trial to Reduce IDDM in the Genetically at Risk), led in the U.S. by principal investigator Dorothy Becker, M.D., professor of pediatrics at Children's Hospital and the University of Pittsburgh School of Medicine, embarked on a large-scale study of 2,159 infants with a family member affected by type 1 diabetes and with genetic risk for type 1 diabetes to find out whether delaying the exposure to complex foreign proteins such as cow's milk proteins would decrease the risk of diabetes.

 

After breastfeeding, infants were either weaned to a special formula (extensively hydrolyzed casein formula), with the cow's milk proteins split into small peptides (small pieces of the protein), or a regular cow's milk-based formula with intact cow's milk proteins.

 

Infants were fed the study formula for at least two months until the age of 6 to 8 months and at the same time were given no cow's milk proteins from any other food sources. The children were followed for at least 10 years to determine which children developed diabetes.

 

At 11.5 years of follow up, weaning to an extensively hydrolyzed casein formula during infancy did not result in a reduction in the incidence of type 1 diabetes compared to regular, intact cow's-milk-based formula.

 

"After more than 15 years of effort, this study puts to rest the controversy regarding the potential role of cow's milk formula in the development of type 1 diabetes," said Becker. "This once more shows us that there is no easy way to prevent type 1 diabetes.

 

Accordingly, there is no evidence to revise the current dietary recommendations for infants at high risk for type 1 diabetes. We need to chip away at our research efforts around the world to find interventions that may change the pre-diabetes course. Ongoing work of our study is doing just that."

 

Abstract

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).

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