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）：作为对RFA DK-08-011的回应，范德比尔特大学（自2006年起为TrialNet主要附属公司）拟成为临床中心。William E.罗素，医学博士，TrialNet PI，将继续担任这一角色。他与詹姆斯·W。托马斯医学博士，作为合作研究者。这项建议的要点： （范德比尔特于2006年10月成为TrialNet的活跃主要附属公司（MA），28个月前。利用MA的适度资源，我们招募了来自12个州的591名受试者进入自然史研究;招募了2名受试者进入口服胰岛素预防试验，4名受试者进入CTLA 4-Ig研究。我们是唯一一家参与这项干预研究的MA。我们还招募了来自51个家庭的433名受试者加入T1糖尿病遗传学联盟，使我们成为国际领先的T1 DGC招募网站。 (We记录对TrialNet的目标和活动的强有力的机构支持，包括：儿科主任Jonathan Gitlin博士承诺资助额外的1.0 FTE TrialNet研究协调员; CTSA主任Gordon Bernard博士的大力支持，提供CRC的全面服务; Alvin Powers博士承诺扩大VEDC的专用空间，提供0.5 FTE的行政支持，并为TrialNet提供范德比尔特糖尿病中心的全部资源。 (The研究者经验丰富，非常适合实现TrialNet临床中心的目标。在范德比尔特TrialNet科学咨询委员会的投入下，他们提出了一项糖尿病干预试验“联合炎症阻断和口服耐受干预T1 D。" (New提出了战略和联盟，以促进临床中心一级TrialNet研究的招募。其中包括与田纳西州卫生部和其他机构的伙伴关系，这些机构对我们地区的影响很大。建议远程招募计划和可能的Mibile临床研究单位，以使我们的筛选活动远远超出中TN。 （已经成立了一个TrialNet社区咨询委员会，以确保本地区各种糖尿病利益攸关方对筛查和外联战略的投入。 公共卫生相关性：1型糖尿病是由于免疫系统对体内产生胰岛素的β细胞的损害而引起的。1型糖尿病的预防需要识别具有糖尿病相关自身免疫易感性的个体，并使用策略使患者的免疫系统保持对β细胞中蛋白质的耐受性。1型糖尿病是一种以预防或改善1型糖尿病为目的的疾病。范德比尔特大学将非常荣幸地继续作为临床中心参与TrialNet。