Proposal as a Clinical Center for Treatment

作为临床治疗中心的提案

• 批准号: 6927118
• 负责人: FRANCINE R. KAUFMAN
• 金额: $ 31.66万
• 依托单位: CHILDREN'S HOSPITAL OF LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-29 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6927118
• 关键词: adolescence (12-20); antiidiotype antibody; blood tests; clinical trials; combination therapy; cooperative study; cytoprotection; diabetes mellitus therapy; disease /disorder prevention /control; drug interactions; enzyme linked immunosorbent assay; flow cytometry; gamma globulin; human subject; human therapy evaluation; immunoregulation; immunotherapy; insulin; insulin dependent diabetes mellitus; longitudinal human study; middle childhood (6-11); pancreatic islets; patient oriented research; pediatrics; sirolimus; statistics /biometry

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.

描述（由申请人提供） 糖尿病预防试验-1的继续，因为TrialNet将尝试 预防或延迟临床糖尿病的发作或保留残余的β细胞 在高危人群或新诊断疾病人群中发挥作用。这 申请将是为了孩子的延续？s医院洛杉矶 TrialNet中的临床中心并完成糖尿病预防试验-1 议定书研究申请的具体目的是确定是否 静脉注射免疫球蛋白（IVIG）（+）雷帕霉素4个月可保存 8-18岁新发受试者的残余β细胞功能。残留β细胞 将通过C肽对混合膳食耐受性的反应来评估功能 Test.血糖控制和B和T标志物的次要结局指标 将跟踪对β-细胞抗原的细胞免疫应答。