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Nutritional Intervention to Prevent (NIP) Type 1 Diabetes A Pilot Trial

University of Colorado, Denver, peter.chase{at}uchsc.edu

Ellen Lescheck, MD

National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland

Lisa Rafkin-Mervis, MS, CDE

University of Miami, Miami, Florida

Heidi Krause-Steinrauf, MS

George Washington University, Washington, DC

Sonia Chritton, MS

University of Colorado, Denver

Smita M. Asare

George Washington University, Washington, DC

Sara Adams

George Washington University, Washington, DC

Jay S. Skyler, MD

University of Miami, Miami, Florida

Michael Clare-Salzler, MD

University of Florida, Gainesville

, and the Type 1 Diabetes TrialNet NIP Study Group

The objective of this study was to describe a pilot trial of using an omega-3 fatty acid (docosahexaenoic acid [DHA]) to prevent islet cell autoimmunity in infants with an increased risk for developing type 1 diabetes (T1D). Infants from pregnant mothers who either have T1D (or the father or a previous child has T1D) and who entered the study in the third trimester or infants younger than age 5 months having a first-degree family member with T1D were eligible for the study. Infants from either group also had to have an increased genetic (HLA) risk for T1D (or multiple first-degree relatives with T1D) to be eligible. The study is a multicenter, 2-arm, randomized, double-masked clinical trial that will last 4 years (1 year of recruitment and 3 years of treatment). Treatment with DHA (or control) began in the last trimester of pregnancy or in the first 5 months after birth. Inflammatory mediators, including cytokines, chemokines, eicosanoids, and C-reactive protein, are being measured along with fatty acids in maternal and infant blood. Ninety-eight infants were enrolled (41 during pregnancy and 57 in the 5 months after birth). HLA results of the 97 eligible infants (1 infant had a protective 0602 allele and was thus ineligible) showed that 90 have DR3 and/or DR4. Seven infants were enrolled without DR3/4 but who instead had multiple first-degree relatives with T1D. Compliance has been excellent, and no families have discontinued participation. Intervention trials in this high-risk group are feasible but require significant effort to identify potential participants.

Key Words: diabetes (type 1 and 2) • chronic disease management • prevent type 1 • nutritional intervention

ICAN: Infant, Child, & Adolescent Nutrition, Vol. 1, No. 2, 98-107 (2009)
DOI: 10.1177/1941406409333466


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