Proposal as a Clinical Center for Treatment

描述（由申请人提供） TrialNet 将继续进行糖尿病预防试验 1 预防或延缓临床糖尿病的发作或保留残留的 β 细胞 在高危人群或新诊断疾病的人群中发挥作用。这个 申请将用于继续洛杉矶儿童医院 TrialNet 临床中心并完成糖尿病预防试验 1 协议。研究应用的具体目标是确定是否 静脉注射免疫球蛋白 (IVIG) ( ) 雷帕霉素 4 个月可保存 8-18 岁新发病受试者的残余 β 细胞功能。残余β细胞 功能将通过 C 肽对混合膳食耐受性的反应来评估 测试。血糖控制的次要结果测量以及 B 和 T 标记物 随后将跟踪对β细胞抗原的细胞免疫反应。

DESCRIPTION (provided by applicant) The continuation of the Diabetes Prevention Trial-1 as TrialNet will attempt to prevent or delay the onset of clinical diabetes or preserve residual beta-cell function in populations at risk or in those with newly diagnosed disease. This application will be for the continuation of the Children?s Hospital Los Angeles Clinical Center in TrialNet and to complete the Diabetes Prevention Trial-1 protocol. The specific aims of the research application will be to determine if Intravenous Immunoglobulin (IVIG) (+) Rapamycin for 4 months can preserve residual beta-cell function in new onset subjects ages 8-18. Residual beta-cell function will be assessed by the C-peptide response to a Mixed Meal Tolerance Test. Secondary outcome measures of glycemic control and markers of the B and T cell immunologic response to beta-cell antigens will be followed.