RANDOMIZED CONTROLLED TRIAL OF THE EFFECT OF GLUTEN-FREE DIET ON BETA-CELL SURV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Patients with newly diagnosed Type 1 diabetes will be screened. Approximately 50 children will need to be screened to identify 12 children for randomization into the study groups, based on preliminary data (60 was requested through the HRPO to account for drop-out). 5 mL of blood by venipuncture will be drawn. Blood drawing will be done at the time of medically indicated blood work when possible, and children will be offered EMLA cream (topical anesthetic). Samples will be assayed by ELISA for zonulin. Children that have elevated zonulin levels, will be invited to participate. They will be randomized into controls (n=6) and intervention (GFD) (n=6). A mixed meal challenge test will be done to assess pancreatic reserve: Pediasure or Ensure is given po to a fasting subject, and then blood is drawn at baseline and in 90 min for C-peptide and zonulin measurement (20 ml total). HLA typing is done at this first test. This test will be repeated evey 3 months for one year or until C-peptide = 0 (no reserve). Immediately after randomization, the intervention group will be taught how to follow a gluten-free diet (GFD) and will be asked to follow this throughout the duration of the study. All subjects will have their diabetes managed according to the standard of care by their endocrinologist. Insulin requirements will also be tracked as a secondary measurement of pancreatic reserve.