Vanderbilt University: Clinical Center Application, Type 1 Diabetes TrialNet

范德比尔特大学：临床中心申请，1 型糖尿病 TrialNet

• 批准号: 7938050
• 负责人: WILLIAM E RUSSELL
• 金额: $ 52.22万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938050
• 关键词: Advisory Committees; Autoimmunity; Beta Cell; Clinical; Clinical Research; Communities; Diabetes Mellitus; Diabetes prevention; Enrollment; Family; Funding; Goals; Immune; Immune system; Individual; Inflammatory; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Studies; Intervention Trial; Natural History; Oral; Patients; Pediatrics; Predisposition; Prevention; Proteins; Recruitment Activity; Research Personnel; Resources; Role; Screening procedure; Secure; Services; Site; Universities; diabetes mellitus genetics; experience; oral tolerance; outreach; programs; public health relevance; response

DESCRIPTION (provided by applicant): In Response to RFA DK-08-011, Vanderbilt University, a TrialNet Major Affiliate since 2006, proposes to become a Clinical Center. William E. Russell, MD, TrialNet PI, will continue in that role. He is joined by James W. Thomas MD, as the Co-Investigator. Salient points of this proposal: (Vanderbilt became an active Major Affiliate (MA) of TrialNet in October, 2006, 28 months ago. With the modest resources of a MA we have recruited 591 subjects from 12 states into the Natural History Study; enrolled 2 subjects into the Oral Insulin Prevention Trial, and four subjects into the CTLA4-lg study. We are the only MA to engage in this intervention study. We have also recruited 433 subjects from 51 families into the T1 Diabetes Genetics Consortium, making us the leading T1DGC recruitment site internationally. (We document an strong institutional support for the goals and activities of TrialNet, including: a commitment by Dr. Jonathan Gitlin, Chair of Pediatrics to fund an additional 1.0 FTE of TrialNet study coordinator; the strong endorsement of Dr. Gordon Bernard Director of the CTSA offering the full services of the CRCs; and a commitment by Dr. Alvin Powers to expand dedicated space in the VEDC, provide 0.5 FTE of administrative support, and the full resources of the Vanderbilt Diabetes Center for TrialNet. (The investigators are highly experienced and well-suited to carrying out the aims of a TrialNet Clinical Center. With the input of a Vanderbilt TrialNet Scientific Advisory Committee, they propose a diabetes intervention trial "Combined inflammatory blockade and oral tolerance for intervention in T1D." (New strategies and alliances are proposed to facilitate recruitment to TrialNet studies at the level of a Clinical Center. Among them are partnerships with the TN Department of Healt and other instutitions with a far reach into our region. A Remote Recruitment Program and possible Mibile Clinical Research Unit are proposed to take our screening activities far beyond middle TN. (A TrialNet Community Advisory Board has been established to secure input regarding screening and outreach strategies from a variety of diabetes stakeholders in our region. PUBLIC HEALTH RELEVANCE: Type 1 diabetes results from immune damage to the body's insulin producing, beta cells. Type 1 diabetes prevention requires identification of individuals with a predisposition to diabetes-related autoimmunity and the use of strategies to allow the patient's immune system to remain tolerant of proteins in the beta cells. Type 1 Diabetes TrialNet is a consortium of sites aimed at the prevention or amelioration of type 1 diabetes. Vanderbilt University would be highly honored to continue to participate in TrialNet as a Clinical Center.

描述（由申请人提供）：响应RFA DK-08-011，范德比尔特大学（Vanderbilt University）是自2006年以来的试用网络主要会员，建议成为临床中心。威廉·E·罗素（William E.詹姆斯·W·托马斯（James W.该提案的重要点： （范德比尔特（Vanderbilt）于2006年10月在28个月前成为了一名活跃的主要会员（MA）。在MA的适度资源中，我们已经招募了来自12个州的591名受试者进入自然历史研究；将2个受试者招募到口服胰岛素预防试验中，并参与CTLA4-LG研究的四个主题。 T1糖尿病遗传学联盟，使我们成为国际领先的T1DGC招聘部位。 （我们记录了针对试验网的目标和活动的强烈机构支持，包括：乔纳森·吉特林博士的承诺，儿科主席乔纳森·吉特林（Jonathan Gitlin）博士为额外的1.0 FTE试验网研究协调员提供了1.0 FTE；戈登·伯纳德（Gordon Bernard）博士的CTSA主管的强烈认可，为CRCS提供了全面的服务。行政支持，以及范德比尔特糖尿病中心的全部资源。 （研究人员非常有经验，非常适合进行试验网临床中心的目标。在范德比尔特试验网科科学咨询委员会的意见下，他们提出了一项糖尿病干预试验“联合炎症性阻滞和口服耐受性，用于干预T1D。” （提出了新的策略和联盟，以促进临床中心级别的试验网研究招募。其中是与TN HEAT部门和其他Intutition的合作伙伴关系，并提出了远距离进入我们地区的远程招聘计划，并提出了可能的Mibile临床研究单位，以使我们的筛查活动远远超出了中间TN。 （已经建立了一个试验网络社区顾问委员会，以确保我们地区各种糖尿病利益相关者的筛查和外展策略的意见。 公共卫生相关性：1型糖尿病是由于对人体产生的β细胞的免疫损害而引起的。 1型预防糖尿病需要鉴定具有与糖尿病相关自身免疫性易感性的个体，并使用策略，以使患者的免疫系统能够耐受β细胞中蛋白质的耐受性。 1型糖尿病试验网是一个旨在预防或改善1型糖尿病的部位的财团。范德比尔特大学（Vanderbilt University）将很荣幸能够继续参加试用网络作为临床中心。