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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 新诊断的1型糖尿病患者将接受筛查。将需要对大约50名儿童进行筛查，以确定12名儿童，根据初步数据随机进入研究组(60名儿童是通过HRPO要求说明辍学的)。通过静脉穿刺法抽取血液5毫升。如果可能，将在进行医学检查时进行抽血，并向儿童提供EMLA乳膏(局部麻醉剂)。样品将用酶联免疫吸附试验检测带菌灵。水平升高的儿童将被邀请参加。随机分为对照组和干预组，每组6例。将进行混合餐激发试验以评估胰腺储备：空腹受试者给予儿科Sure或确保给药，然后在基线和90分钟内抽血测定C肽和带状蛋白(总共20毫升)。人类白细胞抗原基因分型是在第一次测试中完成的。这项测试将每3个月重复一年或直到C肽=0(无储备)。随机化后，干预组将立即学习如何遵循无麸质饮食(GFD)，并将被要求在整个研究期间遵循这一原则。所有受试者都将根据内分泌学家的护理标准来管理他们的糖尿病。胰岛素需求量也将被跟踪，作为胰腺储备的二次测量。

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.