Type 1 Diabetes TrialNet Indiana University Clinical Ce*

1 型糖尿病 TrialNet 印第安纳大学临床中心*

• 批准号: 7109335
• 负责人: HENRY RODRIGUEZ
• 金额: --
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/7109335
• 关键词: adolescence (12-20); blood tests; clinical trials; cooperative study; cytokine receptors; cytoprotection; diabetes mellitus therapy; disease /disorder prevention /control; genetic susceptibility; human subject; human therapy evaluation; immunoglobulin G; immunologic assay /test; immunoregulation; immunosuppressive; immunotherapy; insulin; insulin dependent diabetes mellitus; interleukin 2; longitudinal human study; middle childhood (6-11); monoclonal antibody; pancreatic islets; patient oriented research; pediatrics; statistics /biometry

DESCRIPTION (provided by applicant) Type 1 diabetes arises in genetically predisposed individuals as a consequence of T-cell mediated immune-mediated destruction of the pancreatic islet insulin secreting beta-cells. The onset of clinical symptoms of diabetes represents the endpoint of a chronic progressive decline in beta-cell function, and occurs when the majority of beta-cells have been lost. The Diabetes Prevention Trial -Type 1 (DPT-1) has shown that Type 1 diabetes can be predicted with a high degree of accuracy in relatives of patients with Type 1 diabetes by the presence of autoantibodies and evidence of pancreatic beta-cell dysfunction. The study has shown that cooperative research in Type 1 diabetes can be efficiently coordinated on a national and international level and has enabled identification of a large number of type-1 diabetes patients at the very early stages of their disease. Evidence, both in animal models of type-1 diabetes and in human trials, has shown that it is possible to alter the course of beta-cell destruction utilizing various interventions. DPT-1 has sought to determine whether insulin, when used as an antigen-based therapy, can delay the development of type 1 diabetes in at-risk individuals. Many potential interventions have not been considered because of their toxicities. Recently, several novel immunologic agents, that appear to be promising in the treatment of autoimmune diabetes, have been characterized in investigations of other autoimmune disorders and in the field of organ transplantation. The next logical step is to build upon the success of DPT-1 in identifying at-risk individuals by expanding its infrastructure to investigate additional agents that may lead to the prevention of the disease. Type-1 Diabetes TrialNet will assume this role and will further define the epidemiology and immunologic basis of Type 1 diabetes. We propose to participate in Type 1 Diabetes TrialNet as a Clinical Center. We have successfully served as a RRCC site in DPT-1 and we wish to apply our strengths in subject recruitment and clinical investigation to the collaborative effort represented by TrialNet. An important part of our application is the plan to investigate the potential role of Daclizumab (Zenapax) in the prevention of type 1 diabetes. We have enrolled and randomized 10 individuals to this novel treatment trial over the last 7 months. Our commitment to this line of investigation is evidenced by our efforts and success in designing and successfully implementing this protocol. Our participation as a Clinical Center in TrialNet will enable us to contribute our resources in a united attempt to improve our knowledge of type 1 diabetes and prevent the disease.

描述（由申请人提供） 因此，1 型糖尿病发生在有遗传倾向的个体中 T 细胞介导的免疫介导的胰岛胰岛素破坏 分泌β细胞。糖尿病临床症状的出现代表 β细胞功能慢性进行性衰退的终点，并发生 当大部分β细胞丢失时。糖尿病预防试验 - 1 型 (DPT-1) 已表明 1 型糖尿病可以通过高预测 1 型糖尿病患者亲属的准确度 自身抗体的存在和胰腺β细胞功能障碍的证据。 研究表明，1型糖尿病的合作研究可以 在国家和国际层面进行有效协调，并已使 及早发现大量1型糖尿病患者 他们的疾病阶段。 1 型糖尿病动物模型和 人体试验表明，改变 β 细胞的进程是可能的 利用各种干预措施进行破坏。 DPT-1 试图确定 当胰岛素用作基于抗原的疗法时，是否可以延迟 高危人群罹患 1 型糖尿病。很多潜力 由于其毒性，尚未考虑干预措施。最近， 几种新型免疫制剂，在治疗中似乎有希望 自身免疫性糖尿病，已在其他研究中得到表征 自身免疫性疾病和器官移植领域。 下一个合乎逻辑的步骤是在 DPT-1 的成功基础上再接再厉 通过扩大其基础设施来调查其他高危人群 可能导致疾病预防的药物。 1 型糖尿病 TrialNet 将承担这一角色并将进一步定义流行病学和免疫学 1型糖尿病的基础。 我们建议作为临床中心参与 1 型糖尿病 TrialNet。我们 已成功充当 DPT-1 中的 RRCC 站点，我们希望应用我们的 受试者招募和临床研究方面的优势 以 TrialNet 为代表的协作努力。我们的一个重要组成部分 申请是研究 Daclizumab 潜在作用的计划 （Zenapax）预防 1 型糖尿病。我们已经入组并随机化 在过去 7 个月内，有 10 个人参与了这项新颖的治疗试验。我们的 我们的努力证明了对这一调查线的承诺 成功设计并成功实施该协议。我们的 作为 TrialNet 的临床中心的参与将使我们能够贡献我们的 共同努力提高我们对 1 型糖尿病的了解和 预防疾病。