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Type 1 diabetes risk unaffected by cutting cow’s milk consumption in infants
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Over 10 years of follow-up, the risk for type 1 diabetes was not reduced when infants with genetic susceptibility to the disease were weaned to formula containing no intact proteins compared with a conventional formula, according to study findings published in JAMA.
“Some epidemiological and immunological studies suggest that exposure to complex foreign proteins in early infancy may increase the risk of beta-cell autoimmunity and type 1 diabetes in genetically susceptible individuals, although others do not,” according to study background.
Mikael Knip, MD, DMSc, professor at the University of Helsinki in Finland, and colleagues evaluated data from the Trial to Reduce Insulin-Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) study on 2,159 infants with human leukocyte antigen genotypes and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007. Researchers sought to determine whether weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. Follow-up was conducted until Feb. 28, 2017; median follow-up was 11.5 years. Participants were randomly assigned to an extensively hydrolyzed casein-based formula (n = 1,081) or a conventional adapted cow’s milk formula supplemented with 20% of the casein hydrolysate (control; n = 1,078). Infants were fed the study formula for at least 60 days by age 6 to 8 months, and parents were asked not to feed the infants any baby foods that contained bovine products during the study.
Mean age at the time of study formula introduction was similar between the two groups (intervention group, 2 months; control group, 1.8 months). Mean duration of study-formula feeding was higher in the control group compared with the intervention group (11.7 weeks vs. 10.2 weeks; P < .001).
Diabetes developed in more participants in the intervention group (8.4%) compared with the control group (7.6%) for a difference of 0.8% (P = .47). No significant difference was observed between the two groups for median age at diabetes onset (intervention group, 6 years vs. control group, 5.8 years).
The frequencies of any infection, upper respiratory infections and other adverse events were similar between the two groups.
“The TRIGR trial was a success in providing a definite answer to a controversial issue: Is it possible to reduce the cumulative incidence of type 1 diabetes by weaning at-risk babies to an extensively hydrolyzed formula by avoiding early exposure to cow’s milk proteins? This answer is important irrespective of a positive or negative outcome,” Knip told Endocrine Today. “Only a large trial with adequate power, such as TRIGR, can provide a final answer to this question. There is no benefit in terms of type 1 diabetes risk of using an extensively hydrolyzed formula in the infant period in offspring at increased disease risk.” – by Amber Cox
For more information:
Mikael Knip, MD, DMSc, can be reached at mikael.knip@helsinki.fi.
Disclosures: Knip reports he receives grants from NIH. Please see the study for all other authors’ relevant financial disclosures.
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