Study shows decrease in type 1 diabetes linked to baby formulas.

Dr. Fran Cogen Health Pro
  • Let's trek back to an older blog when I discussed the risk of diabetes and related it to the "Sword of Damocles." In that Finnish study published by Dr. Knip in Diabetes Care, you may recall that the authors concluded that a one time screening for GADAs and IA-2As in the general population in Finland would identify approximately 60 percent of those individuals who will develop type 1 diabetes over the next 27 years. Most importantly, those subjects who have both autoantibodies would carry an extremely high risk for diabetes. The next question is deciding if it is worth doing universal screening for type 1 diabetes if there is no cure at present? My conclusion was that if we have the ability to pinpoint who may develop type 1 diabetes and then prevent it, a significant intervention would then become universal.

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    Enter again Dr. Knip et. al. from Finland, following up his study in Diabetes Care with significant information published in a November 11, 2010, paper in The New England Journal of Medicine: Dietary Intervention in Infancy and Later Signs of Beta-Cell Autoimmunity (NEJM 363;20, November 11, 2010). I would like to provide a bit of background. There is a very high association of type 1 diabetes in Scandinavian countries. One hypothesis is the lack of Vitamin D secondary to decreased sunlight in the northern latitudes may be associated with an increased risk of developing T1DM. Another is the high frequency of the HLA genetic alleles that predispose to type 1 diabetes in Scandinavian countries. At one point, back in the 1980s and 1990s, it was thought that Scandinavian cows milk may have been the culprit, presumably due to a different protein structure. No evidence-based investigations have been able to demonstrate a causal relationship.


    In this NEJM paper, the author hypothesized that "early exposure to complex dietary proteins may increase the risk of beta-cell autoimmunity and type 1 diabetes in children with genetic susceptibility. Thus, a study was preformed by supplementing breast milk with highly hydrolyzed milk formula in the hopes that use of this alternative milk source would decrease the "cumulative incidence in diabetes-associated autoantibodies in such children."


    The method of a study truly matters when the investigative team is trying to prove a hypothesis. A study may link two facts, but does not necessarily prove that one causes the other. Indeed, the study may demonstrate that one fact is related to the other (correlation). This study, however, was a double-blinded, randomized trial in which 230 infants with HLA demonstrated susceptibility to type 1 diabetes and at least one family member with type 1 diabetes received either a casein hydrolysate formula (experimental intervention) or a control of typical cow's based formula (if breast milk was not available during the first 6-8 months of life). The intervention formula was Nutramigen and the control formula was composed specifically for this study (80 percent intact milk protein -Enfamil- and 20 percent hydrolyzed milk protein made to taste identical to Nutramigen). Autoantibodies to insulin (GAD-65, IA-2, and zinc transporter 8) were analyzed as well as islet cell antibodies. The subjects were observed for a median of 10 years (average 7.5 years) and were monitored for the development of type 1 diabetes until they were 10 years old.


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    The results demonstrated that feeding with the casein hydrolysate formula was associated with a decrease in the risk of sero-conversion to positivity for islet-cell antibodies, IA-2 autoantibodies and at least one autoantibody. Type 1 diabetes developed in 16 children (7 percent) by the time they were 10 years of age:  seven of the 113 children in the casein hydrolysate group (6 percent) and nine of the 117 children in the control group (8 percent). The mean age at diagnosis was 4.8 years.


    Knip's study demonstrated that among children with a high risk HLA genotype for type 1 diabetes in association with a first degree relative with T1DM, weaning to a highly hydrolyzed formula during infancy was associated with fewer signs of beta-cell autoimmunity up to 10 years of age. The study did not conclude that there was a definitive progression to overt type 1 diabetes in the conventional cow's milk group. However, the authors note that there is an ongoing study-TRIGR (Trial to Reduce IDDM in the Genetically at Risk) in 15 countries on three continents with enough subjects to address this concern. Thus, it really may be possible that a dietary intervention may have a preventative effect at decreasing the risk of developing type 1 diabetes.


    What practical advice would I suggest? If you have a first degree relative with T1DM, I would consider using a casein hydrolysate formula after weaning your infant from breast milk (confer with your pediatrician). In addition, I would either discuss HLA typing to determine your child's risk of T1DM (highly expensive) or become involved in the Trialnet study.


    I will continue to keep you updated.



Published On: December 01, 2010