NATURAL HISTORY OF THE DEVELOPMNT OF TYPE 1 DIABETES

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。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中心合作。该网络致力于1型糖尿病（T1 D）的研究，预防和早期治疗。Trial Net得到了NIH、国家糖尿病与消化系统疾病与肾脏疾病研究所、国家过敏与传染病研究所、国家儿童健康与人类发展研究所、国家研究资源中心、美国卫生与人类服务部、JDRF和ADA的支持。TrialNet将开发分为两大类的临床试验：针对新诊断的T1 D患者的试验和针对有T1 D风险的患者的试验。 T1 D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。这项研究的目的是获得有关T1 D发病机制和自然史的信息，并促进招募和评估可能有资格参加T1 D预防试验的个人。 受试者将为非糖尿病患者，年龄1-45岁，且有兄弟姐妹、子女或父母患有T1 D，或为非糖尿病患者，年龄1-20岁，且有堂兄弟姐妹、阿姨、叔叔、侄女、侄子、同父异母兄弟姐妹或祖父母患有T1 D。 该研究分为三个阶段：筛选（第1阶段）、基线风险评估（第2阶段）和随访风险评估（第3阶段）。每个阶段都需要单独的知情同意书才能进入。 第1阶段包括通过基础抽血筛查与T1 D相关的自身抗体的存在。自身抗体检测呈阳性的受试者将有资格进入研究的第2阶段，即基线风险评估。对于自身抗体检测不呈阳性的18岁以下的1期受试者，将每年邀请其返回进行1期筛选。第2阶段，基线风险评估，是一次访问（对于大多数患者），需要更深入的实验室测量，以确定参与者患糖尿病的风险。在第3阶段，随访风险评估期间，参与者将在五年内每隔六个月接受一次随访，或直至研究结束。 根据风险评估有资格参加预防试验的受试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.