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，自 2006 年起成为 TrialNet 主要附属机构的范德比尔特大学提议成为临床中心。 William E. Russell（医学博士、TrialNet PI）将继续担任这一职务。 James W. Thomas 医学博士作为联合研究员加入了他的行列。该提案的要点： （范德比尔特于 2006 年 10 月，即 28 个月前，成为 TrialNet 的活跃主要会员 (MA)。凭借 MA 的有限资源，我们已从 12 个州招募了 591 名受试者参加自然历史研究；将 2 名受试者纳入口服胰岛素预防项目试验，四名受试者参加 CTLA4-lg 研究。我们是唯一参与这项干预研究的 MA。我们还招募了来自 51 个家庭的 433 名受试者。 T1 糖尿病遗传学联盟，使我们成为国际领先的 T1DGC 招募网站。 （我们记录了对 TrialNet 目标和活动的强有力的机构支持，包括：儿科主席 Jonathan Gitlin 博士承诺资助额外 1.0 FTE 的 TrialNet 研究协调员； CTSA 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 的行政支持以及 CRC 的全部资源TrialNet 范德比尔特糖尿病中心。 （研究人员经验丰富，非常适合实现 TrialNet 临床中心的目标。在范德比尔特 TrialNet 科学咨询委员会的意见下，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 T1D。 ” （提出了新的战略和联盟，以促进临床中心层面 TrialNet 研究的招募。其中包括与田纳西州卫生部门和其他深入我们地区的机构的合作伙伴关系。远程招募计划和可能的移动临床建议研究单位将我们的筛选活动远远超出中田纳西州。 （已经成立了 TrialNet 社区咨询委员会，以确保我们地区各糖尿病利益相关者就筛查和推广策略提供意见。 公众健康相关性：1 型糖尿病是由人体产生胰岛素的 β 细胞的免疫损伤引起的。 1 型糖尿病的预防需要识别具有糖尿病相关自身免疫倾向的个体，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 TrialNet 是一个旨在预防或改善 1 型糖尿病的网站联盟。范德比尔特大学非常荣幸能够继续作为临床中心参与 TrialNet。