Type 1 Diabetes TrialNet at Indiana University Clinical Center

印第安纳大学临床中心 1 型糖尿病 TrialNet

• 批准号: 9113605
• 负责人: LINDA A DIMEGLIO
• 金额: $ 45.86万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-20 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9113605
• 关键词: Address; Antibodies; Antithymoglobulin; Autoantibodies; Beta Cell; Biological Markers; CD3 Antigens; CSF3 gene; Cell physiology; Cells; Cellular biology; Chronic; Clinical; Clinical Sciences; Clinical Trials Network; Conduct Clinical Trials; Databases; Development; Diabetes Mellitus; Diabetes prevention; Disease; Enrollment; Functional disorder; Future; Genetic; Genetic Predisposition to Disease; Goals; Health; Hyperglycemia; Illinois; Immune; Immunologics; Indiana; Individual; Institutes; Insulin; Insulin-Dependent Diabetes Mellitus; International; Intervention; Islets of Langerhans; Kentucky; Lead; Leadership; Measures; Mediating; Metabolic; Michigan; Monitor; Natural History; Ohio; Oral; Participant; Pathway interactions; Patient Care; Patients; Persons; Physiological; Positioning Attribute; Prevention; Prevention trial; Protocols documentation; Randomized; Relative Risks; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Risk; Site; Solid; Staging; Suggestion; Symptoms; Testing; Time; Training; Translational Research; Universities; Vision; Work; base; biomarker discovery; cost; design; eligible participant; follow-up; improved; member; novel; novel strategies; novel therapeutics; outreach; patient population; prevent; programs; response; rituximab; screening; success

 DESCRIPTION (provided by applicant): Type 1 diabetes (T1D) arises in genetically predisposed individuals as a consequence of the immune- mediated destruction of pancreatic islet insulin- secreting beta cells. The onset of clinical symptoms of diabetes represents a relative endpoint in the chronic progressive decline of beta cell function, and occurs when a preponderance of beta cell mass is lost. The Diabetes Prevention Trial -Type 1 (DPT-1) and Type 1 Diabetes TrialNet Network have demonstrated that: 1) multi-center cooperative research in T1D can be efficiently coordinated on a national and international level and 2) T1D can be predicted with a high degree of accuracy in relatives of persons with T1D by the presence of autoantibodies and other predisposing metabolic and genetic factors prior to significant hyperglycemia. These studies have enabled identification of a large number of individuals at very early stages of disease. The TrialNet network is committed to further define the pathophysiology of the development of T1D and to conduct clinical trials of interventional agents that may lead to the prevention and/or amelioration of the disease. Indiana University (IU) has been a key member of the TrialNet consortium since its inception in 2003, first as an U.S. Regional Recruitment Center for the DPT-1 study and then as a critical Clinical Center for TrialNet with a wide affiliate network, centrally positioned at the crossroads of Midwestern and Eastern regions. In response to RFA DK-14-016 we outline our accomplishments to date in TrialNet, with a particular focus on leadership in TrialNet trials and studies, our support of collaborative research, our recruitment and outreach plans (including use of affiliate sites in Indiana, Illinois, Michigan, Kentucky, and Ohio), our follow-up and retention plans, and suggestions for increasing the network's cost efficiency. We demonstrate our excellent rates of screening of relatives of persons with T1D through the Pathway to Prevention Study; our solid enrollment and excellent retention for monitoring, prevention, new-onset, and long-term follow-up studies; and our affiliate network expansion by 9 regional sites. In addition, we are engaged in a program of biomarker discovery for prediction and monitoring of progression of T1D and are using the Indiana Clinical and Translational Sciences Institute core resources to identify new patient populations and to explore research barriers to participant participation in open study protocols.

 描述（由申请人提供）：1型糖尿病（T1 D）发生在遗传易感个体中，是免疫介导的胰岛胰岛素分泌β细胞破坏的结果。糖尿病的临床症状的发作代表β细胞功能的慢性进行性下降中的相对终点，并且当β细胞质量的优势丧失时发生。糖尿病预防试验-1型（DPT-1）和1型糖尿病TrialNet网络已经证明：1）T1 D的多中心合作研究可以在国家和国际层面上有效协调，2）在T1 D患者的亲属中，T1 D可以通过自身抗体的存在和其他易感代谢和遗传因素以高度的准确性预测，高血糖症这些研究使得能够在疾病的非常早期阶段识别大量个体。TrialNet网络致力于进一步确定T1 D发展的病理生理学，并对可能导致预防和/或改善疾病的干预药物进行临床试验。 自2003年成立以来，印第安纳州大学（IU）一直是TrialNet联盟的关键成员，首先是DPT-1研究的美国区域招募中心，然后是TrialNet的重要临床中心，拥有广泛的附属网络，集中位于中西部和东部地区的十字路口。作为对RFA DK-14-016的回应，我们概述了我们迄今为止在TrialNet方面取得的成就，特别关注TrialNet试验和研究中的领导地位、我们对合作研究的支持、我们的招募和推广计划（包括使用印第安纳州、伊利诺伊州、密歇根州、肯塔基州和俄亥俄州的附属网站）、我们的后续和保留计划以及提高网络成本效率的建议。我们通过预防途径研究证明了我们对T1 D患者亲属的高筛查率;我们在监测、预防、新发和长期随访研究方面的稳健招募和优秀保留;以及我们通过9个区域站点扩展的附属网络。此外，我们还参与了一项用于预测和监测T1 D进展的生物标志物发现计划，并正在使用印第安纳州临床和转化科学研究所的核心资源来识别新的患者人群，并探索参与开放研究方案的研究障碍。