NIDDK Follow-up on Subjects and Immunological Assessments in The Environmental Determinants of Diabetes In The Young Study (TEDDY) (UC4)

NIDDK 青年糖尿病环境决定因素研究 (TEDDY) (UC4) 中受试者和免疫学评估的后续行动

• 批准号: 10088137
• 负责人: JEFFREY P KRISCHER
• 金额: $ 100万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10088137
• 关键词: Adherence; Architecture; Attention; Autoantibodies; Autoimmunity; Award; B-Lymphocytes; Big Data; Biological; Biological Markers; Celiac Disease; Cells; Characteristics; Childhood diabetes; Clinical; Clinical Investigator; Collaborations; Communication; Communities; Confidentiality of Patient Information; Data; Data Analyses; Data Coordinating Center; Data Management Resources; Data Security; Data Set; Development; Diabetes Mellitus; Diet; Dietary Factors; Disease; Documentation; Educational workshop; Enrollment; Ensure; Etiology; Evaluation; Florida; Gene Expression; Genes; Goals; HLA Antigens; Immune; Immune system; Immunologic Markers; Immunologics; Individual; Infectious Agent; Infectious Diseases Research; Informatics; Insulin-Dependent Diabetes Mellitus; Laboratories; Logistics; Maintenance; Manuals; Measurement; Measures; Messenger RNA; Methods; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Participant; Pathogenesis; Performance; Periodicity; Peripheral Blood Mononuclear Cell; Plasma; Play; Policies; Population; Preparation; Procedures; Process; Proteins; Protocols documentation; Psychosocial Factor; Publications; Quality Control; Research; Research Personnel; Role; Sampling; Sampling Studies; Schedule; Serum; Services; Site Visit; Source; Specific qualifier value; Specimen; Statistical Data Interpretation; Study Subject; Technology; Time; TimeLine; Training; Universities; Visit; antigen-specific T cells; clinical center; data management; data quality; data sharing; data warehouse; diabetes risk; endocrine pancreas development; environmental agent; follow up assessment; follow-up; immunological status; information processing; islet; meetings; metabolomics; microbiome; novel; operation; prevent; recruit; repository; symposium; web site

Abstract The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition RFA. The specific aims of this application are to describe plans to coordinate the recruitment of immune markers collaborator(s) and to continue the DCC's functions in support of TEDDY subject follow-up. The competition will be sufficient to attract applications from collaborators with the capability to perform reliable measurements, and to make the data available to TEDDY investigators for collaborative, integrative analyses. In addition, this application is intended to support the TEDDY DCC for subject follow-up in the final two years of the award. The proposed Data Coordinating Center activities in years 4 and 5 include: 1) Executing the study protocol for follow-up of TEDDY study participants according to schedules and procedures contained in the study's Manual of Operations and in collaboration with the Clinical Centers at which participants are enrolled and with NIDDK staff. 2) Receiving, managing, and analyzing data obtained from the clinical centers 3). Monitoring of adherence to the research plan by conducting site visits to monitor the quality of record keeping, source documentation and the accuracy of data entry and also for overseeing data quality control. Steering Committee, subcommittee, and external evaluation committee meetings and workshops.4). Providing statistical support, expertise and oversight throughout the study. 5) Providing study- wide communications, dissemination of study materials such as protocols, Manual of Operations, forms or other study documents, and development and maintenance of the web site. 6) Playing a key role in the operational conduct of TEDDY, providing training and technical assistance to the Clinical Centers in performance of the follow-up assessments; assisting in protocol implementation; and working in conjunction with the Clinical Centers and NIDDK staff to oversee all aspects of Clinical Center performance, including timeliness and quality of data and biosample submission. 7) Procurement and administration of subcontracts for laboratory services, including: central human leukocyte antigen laboratory; the autoantibody laboratories, the mRNA laboratories, infectious disease laboratories, and other laboratories as needed. 8) Providing administrative and logistical support services for the TEDDY Study Group including preparation of publications, and organizing periodic meetings for the study group and subcommittees, workshops, and conference calls. 9) Transfer of all biosamples and data to the NIDDK central repositories according to a timeline developed with the NIDDK. and 10) Working closely with the Clinical Centers in a collaborative and interactive manner and serving on the Steering Committee.

抽象的 南佛罗里达大学拥有开展本次有限竞赛中指定活动的独特资格 射频消融。该应用程序的具体目的是描述协调免疫招募的计划 标记合作者并继续 DCC 的职能，支持 TEDDY 受试者的后续行动。 竞赛将足以吸引有能力执行的合作者的申请 可靠的测量，并将数据提供给 TEDDY 研究人员进行协作、 综合分析。此外，该应用程序旨在支持 TEDDY DCC 进行受试者随访 在该奖项的最后两年。拟议的数据协调中心在第 4 年和第 5 年的活动包括： 1) 根据时间表和执行TEDDY研究参与者随访的研究方案 程序包含在该研究的操作手册中，并与以下临床中心合作 哪些参与者已注册以及 NIDDK 工作人员。 2) 接收、管理和分析获得的数据 来自临床中心3)。通过实地考察来监测研究计划的遵守情况 记录保存、源文件的质量和数据输入的准确性以及监督 数据质量控制。指导委员会、小组委员会和外部评估委员会会议和 研讨会.4).在整个研究过程中提供统计支持、专业知识和监督。 5）提供学习- 广泛的沟通、传播研究材料，例如方案、操作手册、表格或 其他学习文档以及网站的开发和维护。 6) 发挥关键作用 TEDDY 的运营行为，为以下地区的临床中心提供培训和技术援助 后续评估的表现；协助协议实施；并协同工作 与临床中心和 NIDDK 工作人员一起监督临床中心绩效的各个方面，包括 数据和生物样本提交的及时性和质量。 7) 分包合同的采购和管理 实验室服务，包括：中心人类白细胞抗原实验室；自身抗体实验室， mRNA实验室、传染病实验室和其他需要的实验室。 8) 提供 为 TEDDY 研究小组提供行政和后勤支持服务，包括准备出版物、 组织研究组和小组委员会的定期会议、研讨会和电话会议。 9） 根据 NIDDK 制定的时间表将所有生物样本和数据转移到 NIDDK 中央存储库 NIDDK。 10) 以协作和互动的方式与临床中心密切合作， 在指导委员会任职。

项目成果

Molecular epidemiology of enteroviruses in young children at increased risk of type 1 diabetes.

1 型糖尿病风险增加的幼儿肠道病毒的分子流行病学。

• 发表时间: 2018
• 影响因子: 3.7
• 作者: Sioofy;Oikarinen, Sami;Honkanen, Hanna;Huhtala, Heini;Lehtonen, Jussi P;Briese, Thomas;Hyöty, Heikki;TEDDY Study Group
• 通讯作者: TEDDY Study Group

Disease-modifying therapies and features linked to treatment response in type 1 diabetes prevention: a systematic review.

疾病缓解疗法和与 1 型糖尿病预防治疗反应相关的特征：系统评价。

• 发表时间: 2023-10-05
• 作者: Felton, Jamie L;Griffin, Kurt J;Oram, Richard A;Speake, Cate;Long, S Alice;Onengut;Rich, Stephen S;Monaco, Gabriela S F;Evans;DiMeglio, Linda A;Ismail, Heba M;Steck, Andrea K;Dabelea, Dana;Johnson, Randi K;Uraz
• 通讯作者: Uraz

Analgesic antipyretic use among young children in the TEDDY study: no association with islet autoimmunity.

TEDDY 研究中幼儿镇痛解热药的使用：与胰岛自身免疫无关。

• 发表时间: 2017
• 影响因子: 2.4
• 作者: Lundgren, Markus;Steed, Leigh Johnson;Tamura, Roy;Jonsdottir, Berglind;Gesualdo, Patricia;Crouch, Claire;Sjöberg, Maija;Hansson, Gertie;Hagopian, William A;Ziegler, Anette G;Rewers, Marian J;Lernmark, Åke;Toppari, Jorma;She, Jin;Akolka
• 通讯作者: Akolka

Dynamic changes in immune gene co-expression networks predict development of type 1 diabetes.

免疫基因共表达网络的动态变化可预测 1 型糖尿病的发生。

• 发表时间: 2021-11-22
• 影响因子: 4.6
• 作者: Brænne, Ingrid;Onengut;Chen, Ruoxi;Manichaikul, Ani W;Rich, Stephen S;Chen, Wei;Farber, Charles R;TEDDY Study Group
• 通讯作者: TEDDY Study Group

Complete blood counts with red blood cell determinants associate with reduced beta-cell function in seroconverted Swedish TEDDY children.

具有红细胞决定因素的全血细胞计数与血清转化的瑞典 TEDDY 儿童的 β 细胞功能降低相关。

• 发表时间: 2021-07
• 作者: Salami, Falastin;N Tamura, Roy;Elding Larsson, Helena;Lernmark, Åke;Törn, Carina;TEDDY Study Group
• 通讯作者: TEDDY Study Group