Vanderbilt University: Clinical Center Application, Type 1 Diabetes TrialNet

描述(申请人提供)：为响应RFA DK-08-011，范德比尔特大学自2006年起成为TrialNet的主要附属机构，建议成为临床中心。TrialNet Pi医学博士威廉·E·罗素将继续担任这一职务。詹姆斯·W·托马斯医学博士作为联合调查员加入了他的行列。这项建议的要点是： (Vanderbilt于2006年10月，即28个月前成为TrialNet的活跃主要附属公司(MA)。利用MA的有限资源，我们从12个州招募了591名受试者参加自然历史研究；招募了2名受试者参加口服胰岛素预防试验，并招募了4名受试者参加CTLA4-LG研究。我们是唯一参与这项干预研究的硕士。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，使我们成为国际上领先的T1DGC招募网站。 (我们记录了对TrialNet的目标和活动的强有力的机构支持，包括：儿科主席Jonathan Gitlin博士承诺为TrialNet研究协调员额外资助1.0FTE；CTSA主任Gordon Bernard博士大力支持为临床试验中心提供全面服务的主任；Alvin Power博士承诺扩大VEDC的专用空间，提供0.5FTE的行政支持，以及Vanderbilt糖尿病中心的全部资源用于TrialNet。 (调查人员经验丰富，非常适合实现TrialNet临床中心的目标。在Vanderbilt TrialNet科学咨询委员会的支持下，他们提出了一项糖尿病干预试验，“结合炎症阻断和口服耐受性干预T1D。” (提出了新的战略和联盟，以促进临床中心级别的TrialNet研究的招募。其中包括与TN卫生部和其他机构的伙伴关系，这些机构在我们地区具有深远的影响。一个远程招募计划和可能的Mibille临床研究单位被提议将我们的筛查活动远远超出TN中期。 (已经成立了TrialNet社区咨询委员会，以确保我们地区的各种糖尿病利益相关者就筛查和推广战略提供意见。 与公共健康相关：1型糖尿病是由于人体产生胰岛素的β细胞受到免疫损伤而导致的。1型糖尿病的预防需要确定糖尿病相关自身免疫易感性的个体，并使用策略允许患者的免疫系统保持对β细胞中蛋白质的耐受。1型糖尿病试验网是一个旨在预防或改善1型糖尿病的网站联盟。范德比尔特大学将非常荣幸地继续作为临床中心参加TrialNet。

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.