The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition RFA. The proposed Data Coordinating Center activities described 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 bio-sample 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 bio-samples 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.

Public Health Relevance

The goal of The Environmental Determinants of Diabetes in the Young Study (TEDDY) is the identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors which trigger type 1 diabetes (T1D) in genetically susceptible individuals. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1D. The Coordinating Center maintains the study protocol and provides project oversight, coordination, communication, statistical analyses and capability to collect longitudinal data and results of laboratory analyses of biological specimens from individuals at risk for diabetes. The TEDDY study includes analyses of dietary biomarkers, metabolomics, gene expression and the micro-biome in assessing characteristics of those developing autoimmunity, Type 1 diabetes and celiac disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
High Impact Research and Research Infrastructure Cooperative Agreement Programs—Multi-Yr Funding (UC4)
Project #
1UC4DK100238-01
Application #
8598768
Study Section
Special Emphasis Panel (ZDK1-GRB-N (M5))
Program Officer
Spain, Lisa M
Project Start
2014-01-01
Project End
2018-12-31
Budget Start
2014-01-01
Budget End
2018-12-31
Support Year
1
Fiscal Year
2014
Total Cost
$24,020,684
Indirect Cost
$2,222,507
Name
University of South Florida
Department
Pediatrics
Type
Schools of Medicine
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33612
Roth, Roswith; Baxter, Judith; Vehik, Kendra et al. (2017) The feasibility of salivary sample collection in an international pediatric cohort: The the TEDDY study. Dev Psychobiol 59:658-667
Krischer, Jeffrey P; Liu, Xiang; Lernmark, Åke et al. (2017) The Influence of Type 1 Diabetes Genetic Susceptibility Regions, Age, Sex, and Family History on the Progression From Multiple Autoantibodies to Type 1 Diabetes: A TEDDY Study Report. Diabetes 66:3122-3129
Lundgren, Markus; Steed, Leigh Johnson; Tamura, Roy et al. (2017) Analgesic antipyretic use among young children in the TEDDY study: no association with islet autoimmunity. BMC Pediatr 17:127
Yang, J; Tamura, R N; Uusitalo, U M et al. (2017) Vitamin D and probiotics supplement use in young children with genetic risk for type 1 diabetes. Eur J Clin Nutr 71:1449-1454
Köhler, Meike; Beyerlein, Andreas; Vehik, Kendra et al. (2017) Joint modeling of longitudinal autoantibody patterns and progression to type 1 diabetes: results from the TEDDY study. Acta Diabetol 54:1009-1017
Lönnrot, Maria; Lynch, Kristian F; Elding Larsson, Helena et al. (2017) Respiratory infections are temporally associated with initiation of type 1 diabetes autoimmunity: the TEDDY study. Diabetologia 60:1931-1940
Johnson, Suzanne Bennett; Lynch, Kristian F; Roth, Roswith et al. (2017) My Child Is Islet Autoantibody Positive: Impact on Parental Anxiety. Diabetes Care 40:1167-1172
Kemppainen, Kaisa M; Vehik, Kendra; Lynch, Kristian F et al. (2017) Association Between Early-Life Antibiotic Use and the Risk of Islet or Celiac Disease Autoimmunity. JAMA Pediatr 171:1217-1225
Koletzko, Sibylle; Lee, Hye-Seung; Beyerlein, Andreas et al. (2017) Caesarean Section on The Risk of Celiac Disease in the Offspring: The Teddy Study. J Pediatr Gastroenterol Nutr :
Steck, Andrea K; Larsson, Helena Elding; Liu, Xiang et al. (2017) Residual beta-cell function in diabetes children followed and diagnosed in the TEDDY study compared to community controls. Pediatr Diabetes 18:794-802

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