NATURAL HISTORY OF THE DEVELOPMNT OF TYPE 1 DIABETES

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。TrialNet是一个由18个临床中心组成的网络，与美国、加拿大、芬兰、英国、意大利、德国、澳大利亚和新西兰的筛查网站合作。该网络致力于1型糖尿病(T1D)的研究、预防和早期治疗。试验网得到了美国国立卫生研究院、国家糖尿病和肾脏疾病研究所、国家过敏和传染病研究所、国家儿童健康和人类发展研究所、国家研究资源中心、美国卫生与公众服务部、JDRF和ADA的支持。TrialNet将开发两大类临床试验：针对新诊断的T1D患者的临床试验和针对T1D风险人群的临床试验。T1D发展的TrialNet自然史研究是一项多中心研究，采用前瞻性队列设计。这项研究的目标是获得有关T1D发病机制和自然病史的信息，并促进招募和评估可能有资格参加T1D预防试验的个体。参与者年龄1-45岁，无糖尿病，有T1D的兄弟姐妹、子女或父母，或非糖尿病，1-20岁，有T1D的表亲、阿姨、叔叔、侄女、侄子、同父异母的兄弟姐妹或祖父母。研究分为三个阶段：筛选(第一阶段)、基线风险评估(第二阶段)和后续风险评估(第三阶段)。每个阶段都需要单独的知情同意才能进入。第一阶段包括通过基本抽血筛查与T1D相关的自身抗体的存在。自身抗体检测呈阳性的参与者将有资格进入研究的第二阶段，即基线风险评估。18岁以下自身抗体检测不呈阳性的第一阶段参与者将被邀请每年回来进行第一阶段筛查。阶段2，基线风险评估，是一次访问(对大多数患者)，需要更深入的实验室测量来确定参与者患糖尿病的风险。在第三阶段，后续风险评估期间，参与者将每隔六个月接受一次探视，为期五年或直到研究结束。根据风险评估有资格参加预防试验的参与者将被邀请参加这些试验。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. TrialNet is a network of 18 Clinical Centers working in cooperation with screening sites throughout the US, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. The network is dedicated to the study, prevention, and early treatment of Type 1 Diabetes (T1D). Trial Net is supported by the NIH, National Institute of Diabetes amp; Digestive amp; Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Center for Research Resources, US Department of Health amp; Human Services, JDRF, and ADA. TrialNet will develop clinical trials that fall into 2 broad categories: those for individuals with newly diagnosed T1D and those for individuals at risk for T1D. The TrialNet Natural History Study of the Development of T1D is a multi-centered study, using a prospective cohort design. The goals of the study are to both gain information about the pathogenesis and natural history of T1D and to facilitate the recruitment and assessment of individuals who might qualify for T1D prevention trials. Participants will be non-diabetic, 1-45 years of age, and have a sibling, child, or parent with T1D or be non-diabetic, 1-20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or grandparent with T1D. The study is divided into three phases: Screening (Phase 1), Baseline Risk Assessment (Phase 2) and Follow-up Risk Assessments (Phase 3). Each phase requires separate informed consent for entry. Phase 1 involves screening via a basic blood draw for the presence of autoantibodies associated with T1D. Participants who test positive for autoantibodies will be eligible for entry into Phase 2 of the study, the Baseline Risk Assessment. Phase 1 participants under 18 years of age who do not test positive for autoantibodies will be invited back yearly for phase 1 screening. Phase 2, Baseline Risk Assessment, is a 1-time visit (for most patients) requiring more in-depth laboratory measurements for determining a participant¿¿s risk of developing diabetes. During Phase 3, Follow-up Risk Assessments, participants will be seen at six-month intervals for five years or until the end of the study. Participants who qualify for prevention trials based on their risk assessments will be invited to participate in those trials as they become available.