Type 1 Diabetes TrialNet at Indiana University Clinical Center

描述（由申请人提供） 1型糖尿病发生在遗传易感个体的结果 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发作代表了 β细胞功能慢性进行性下降的终点，并发生 当大部分的β细胞都丢失了。糖尿病预防试验 -1型（DPT-1）已经表明，1型糖尿病可以预测与高 1型糖尿病患者家属的准确度 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 在国家和国际一级进行有效协调， 早期发现大量1型糖尿病患者 他们的疾病阶段。在1型糖尿病动物模型和 在人体试验中，已经表明有可能改变β细胞的过程， 利用各种干预措施进行破坏。DPT-1试图确定 胰岛素作为一种基于抗原的治疗方法，是否可以延迟 1型糖尿病患者的饮食习惯许多潜在 由于其毒性，尚未考虑采取干预措施。最近， 几种新的免疫剂，似乎是有希望的治疗 自身免疫性糖尿病，已经在其他研究中得到了表征。 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成功识别 通过扩大其基础设施，以调查其他 可能导致疾病预防的药物。1型糖尿病 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加1型糖尿病试验网。我们 我们已成功地作为DPT-1的RRCC站点，我们希望将我们的 受试者招募和临床研究的优势 以TrialNet为代表的协作努力。的重要组成部分 申请是研究Daclizumab的潜在作用的计划 1型糖尿病的治疗方法我们已经招募并随机 在过去的7个月里，有10人参加了这项新的治疗试验。我们 我们对这一调查工作的承诺体现在我们的努力和 成功设计并成功实施该协议。我们 作为临床中心参与TrialNet将使我们能够贡献我们的 资源，共同努力提高我们对1型糖尿病的认识， 预防疾病。

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.