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

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 将对新诊断的1型糖尿病患者进行筛查。根据初步数据（通过HRPO要求60名儿童考虑脱落），需要筛选约50名儿童，以确定12名儿童随机分配至研究组。将通过静脉穿刺抽取5 mL血液。如果可能，将在医学上指示的血液检查时进行抽血，并为儿童提供EMLA霜（局部麻醉剂）。将通过ELISA法测定样品中的zonulin。有高zonulin水平的儿童，将被邀请参加。他们将被随机分为对照组（n=6）和干预组（GFD）（n=6）。将进行混合餐激发试验以评估胰腺储备：对空腹受试者口服Pediasure或Ensure，然后在基线和90分钟内抽血用于C肽和zonulin测量（总计20 ml）。HLA分型在第一次测试中完成。每3个月重复一次，持续一年或直至C肽= 0（无储备）。随机化后，将立即教导干预组如何遵循无麸质饮食（GFD），并要求其在整个研究期间遵循该饮食。所有受试者的糖尿病将由其内分泌科医生根据标准治疗进行管理。还将跟踪胰岛素需求，作为胰腺储备的次要测量。

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.