The competing renewal application is for the SWEDEN Clinical Center of The Environmental Determinants of Diabetes in the Young (TEDDY) study. The primary objective of this multi-center, multi-national, epidemiological study is the identification of infectious agents, dietary factors, or other environmental exposures that are associated with increased risk of islet autoimmunity and type 1 diabetes mellitus (T1D). TEDDY is an observational cohort study in which newborns who are less than 4.5 months of age and have high risk HLA genotypes in the general population or are first-degree relatives of patients affected with T1D will be enrolled.
The specific aims of this SWEDEN Clinical Center renewal application are to: 1) Complete this Center's contribution to the HLA-DR.DQ screening of 361,000 newborns and enrollment of 7,800 high- risk infants into intensive prospective follow-up to achieve the overall TEDDY goals. 2) Refine strategies to retain subjects enrolled in the follow-up and collect all planned biological specimens and epidemiological data according to the standard protocol including close monitoring of performance and sample/data quality. 3) Ascertain prospectively development of islet autoantibodies and clinical T1D in the study subjects. 4) Perform planned laboratory tests at appropriate times using a nested case-control study design to answer specific scientific questions and hypotheses pertinent to the TEDDY study goals. 5) Analyze and publish laboratory and epidemiological data in collaboration with the TEDDY Data Coordinating Center (funded by a separate contract). 6) Guide the ongoing TEDDY project by participation of the Clinical Center investigators and staff in work of the study Steering Committee and sub-committees. Recruitment stared in September 2004 and will continue until December 31, 2009. Eligible children are followed four times per year until 4 years of age and twice a year thereafter until 15 years of age. The frequency of eligible newborns in Sweden is as high as 7.9% and the rate of enrollment is 70% in both the general population and among first degree relatives. The SWEDEN Clinical Center is contributing 37% of the 3500 children enrolled in the study so far. Three children have developed T1 D. Participants will be followed to age 15 years. Identification of environmental factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1 D.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK063861-10
Application #
8313621
Study Section
Special Emphasis Panel (ZDK1-GRB-G (J1))
Program Officer
Spain, Lisa M
Project Start
2003-03-01
Project End
2013-04-30
Budget Start
2012-05-01
Budget End
2013-04-30
Support Year
10
Fiscal Year
2012
Total Cost
$582,137
Indirect Cost
$43,121
Name
Lund University
Department
Type
DUNS #
350582417
City
Lund
State
Country
Sweden
Zip Code
SE-22-100
Uusitalo, Ulla; Liu, Xiang; Yang, Jimin et al. (2016) Association of Early Exposure of Probiotics and Islet Autoimmunity in the TEDDY Study. JAMA Pediatr 170:20-8
Sharma, Ashok; Liu, Xiang; Hadley, David et al. (2016) Identification of Non-HLA Genes Associated with Celiac Disease and Country-Specific Differences in a Large, International Pediatric Cohort. PLoS One 11:e0152476
Yang, Jimin; Lynch, Kristian F; Uusitalo, Ulla M et al. (2016) Factors associated with longitudinal food record compliance in a paediatric cohort study. Public Health Nutr 19:804-13
Törn, Carina; Liu, Xiang; Hagopian, William et al. (2016) Complement gene variants in relation to autoantibodies to beta cell specific antigens and type 1 diabetes in the TEDDY Study. Sci Rep 6:27887
Zhao, Lue Ping; Alshiekh, Shehab; Zhao, Michael et al. (2016) Next-Generation Sequencing Reveals That HLA-DRB3, -DRB4, and -DRB5 May Be Associated With Islet Autoantibodies and Risk for Childhood Type 1 Diabetes. Diabetes 65:710-8
Johnson, Suzanne Bennett; Lynch, Kristian F; Baxter, Judith et al. (2016) Predicting Later Study Withdrawal in Participants Active in a Longitudinal Birth Cohort Study for 1 Year: The TEDDY Study. J Pediatr Psychol 41:373-83
Andrén Aronsson, Carin; Lee, Hye-Seung; Koletzko, Sibylle et al. (2016) Effects of Gluten Intake on Risk of Celiac Disease: A Case-Control Study on a Swedish Birth Cohort. Clin Gastroenterol Hepatol 14:403-409.e3
Haghighi, Mona; Johnson, Suzanne Bennett; Qian, Xiaoning et al. (2016) A Comparison of Rule-based Analysis with Regression Methods in Understanding the Risk Factors for Study Withdrawal in a Pediatric Study. Sci Rep 6:30828
Swartling, Ulrica; Lynch, Kristian; Smith, Laura et al. (2016) Parental Estimation of Their Child's Increased Type 1 Diabetes Risk During the First 2 Years of Participation in an International Observational Study: Results From the TEDDY study. J Empir Res Hum Res Ethics 11:106-14
Zhao, Lue Ping; Bolouri, Hamid; Zhao, Michael et al. (2016) An Object-Oriented Regression for Building Disease Predictive Models with Multiallelic HLA Genes. Genet Epidemiol 40:315-32

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