Type 1 Diabetes TrialNet: Clinical Centers

描述(由申请人提供) 这是一份来自乔斯林糖尿病中心/S儿童医院的申请 当前糖尿病预防试验-1(DPT-1)临床中心将成为 全国1型糖尿病试验网络中的临床中心 糖尿病，试探网。TrialNet，一个全国性的合作临床网络 研究小组将由临床中心和核心支持设施组成。 其共同目标将是进行干预研究，以预防、治疗或 改善人类的1型糖尿病。TrialNet还将支持 接受筛查或登记的人群中的自然历史和遗传学研究 旨在更好地了解病因和疾病的具体研究 1型糖尿病的发病机制和制定预防策略 疾病。 乔斯林糖尿病中心/儿童？S医院提出临床试验网 中心包括经验丰富的人员的扩展资源，此外 扩大关联机构的网络，以开展由 美国国立卫生研究院。我们的临床中心将有两个主要目标：1)要完成 正在进行的DPT-1研究；2.)参与设计和实施 现有和未来用于预防、治疗的新药物的试点和扩展研究 或改善1型糖尿病，也参与并提供 用于遗传和自然历史研究的资源。 正在进行的1型糖尿病预防试验(DPT-1)正在进行测试， 非糖尿病患者早期肠外胰岛素或口服胰岛素干预 患病风险增加的1型糖尿病患者的亲属 可以延缓1型糖尿病的临床发病。DPT-1目前有资金 至2001年8月，TrialNet将受托继续并完成 当前的协议。 我们的乔斯林/S儿童中心致力于为未来的临床做出贡献 1型糖尿病的研究。我们还提出了一种新的介入性方法 方案：胰岛素B链在不完全弗氏？S佐剂中的应用 诊断为1型糖尿病患者在β细胞中测试其预防效果 功能衰退。主要的结果衡量标准是刺激的混合餐 C-肽水平。研究的第一阶段目前正在进行中。

DESCRIPTION (provided by applicant) This is an application from the Joslin Diabetes Center/Children?s Hospital, a current Diabetes Prevention Trial-1 (DPT-1) Clinical Center to become a Clinical Center in the national diabetes trial network for Type 1 diabetes mellitus, the TrialNet. TrialNet, a national network of cooperative clinical research groups will consist of clinical centers and core support facilities. Its common goal will be to perform intervention studies to prevent, treat or ameliorate Type 1 diabetes mellitus in humans. TrialNet will also support natural history and genetic studies in the population screened or enrolled in specific studies aiming to achieve a better understanding of the etiology and pathogenesis of Type 1 diabetes and to develop strategies to prevent the disease. The Joslin Diabetes Center/Children?s Hospital proposed TrialNet Clinical Center includes expanded resources in experienced personnel, in addition to the expanded network of associated institutions to the collaborative effort led by the NIH. Our Clinical Center will have two major objectives: 1.) to complete the ongoing DPT-1 study; 2.) to participate in the design and implementation of existing and future pilot and expanded studies of new agents to prevent, treat or ameliorate Type 1 diabetes mellitus and also to participate and provide resources for genetic and natural history studies. The ongoing Diabetes Prevention Trial for Type 1 Diabetes (DPT-1) is testing, whether early intervention with parenteral or oral insulin in nondiabetic relatives of persons with Type 1 diabetes with increased risk for the disease can delay the clinical onset of Type 1 diabetes. The DPT-1 is currently funded through August 2001 and the TrialNet will be entrusted to carry on and complete the current protocol. Our Joslin/Children?s center is committed to contribute to future clinical studies in Type 1 diabetes mellitus. We also propose a novel interventional protocol, using insulin B-chain in incomplete Freund?s adjuvant in newly diagnosed Type 1 diabetes patients to test its preventive effect in beta cell function decline. The primary outcome measure is mixed meal stimulated C-peptide levels. Phase 1 part of the study is currently underway.