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Type 1 Diabetes - TrialNet e-news - April 2010

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NIP Pilot Study Confirms Value of Larger Study


A pilot study using the nutritional supplement docosahexaenoic acid (DHA) to prevent type 1 diabetes in newborns has confirmed the value of conducting a larger study. The goal of the Nutritional Intervention to Prevent (NIP) Type 1 Diabetes Pilot Trial was twofold: 1) to learn more about the role of DHA in preventing autoantibodies for type 1 diabetes, and 2) to determine whether a full-length study would be feasible, considering how difficult a clinical trial with babies might be. The pilot study was conducted at nine TrialNet locations.

The NIP study succeeded at safely increasing and measuring DHA levels in 90 high-risk infants. Found naturally in mothers’ breast milk and in various foods, DHA is necessary for proper functioning of the brain and healthy growth of an infant’s nervous system and vision.

The study found that those who received DHA supplements (infants or nursing mothers) had a 61-100 percent increase in DHA compared to the untreated group. This was true for both formula and capsule supplements. Just as important, there were no problems with babies accepting the study formula or nursing mothers taking the capsule. No harmful side-effects occurred with either group.

In the same study, six months of DHA supplementation was not successful at reducing cytokine (a major inflammatory marker) in infants. However, there appeared to be some reduction in cytokine levels at 12 and 18 months.

In earlier studies, DHA helped reduce cytokine in adults, but no data was available for infants. The idea that inflammatory cytokines might be involved in the initial development of type 1 diabetes suggested it might be easier to try to prevent autoimmunity than try to reverse it later.  Further study is underway to learn more about how DHA affects inflammatory markers possibly involved in the early development of diabetes.

“We’re pleased to report it is possible to successfully enroll babies in this type of diabetes prevention trial and that families are willing to come in for study visits,” states TrialNet Principal Investigator Peter Chase, M.D., of the University of Colorado Health Sciences Center.

Babies enrolled in this study had a high risk of developing type 1 diabetes based on family history. They received free screening for appearance of type 1 autoantibodies that are seen in people prior to the development of type 1 diabetes. These children can continue to be screened every year, up to age 18.  If a child develops autoantibodies, they will be closely monitored for development of diabetes and also advised if they become eligible for a prevention trial.

“We want to thank all the participating parentsfor their time and willingness to enroll their young children in this important clinical study,” said Dr. Chase. “Their participation is an important step on the pathway to prevention.

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