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Lee, H.S.* ; Burkhardt, B.R.* ; McLeod, W.* ; Smith, S.* ; Eberhard, C.* ; Lynch, K.* ; Hadley, D.* ; Rewers, M.* ; Simell, O.* ; She, J.X.* ; Hagopian, B.* ; Lernmark, A.* ; Akolkar, B.* ; Ziegler, A.-G. ; Krischer, J.P.* ; TEDDY Study Group (Beyerlein, A. ; Bonifacio, E. ; Hummel, M. ; Hummel, S. ; Foterek, K. ; Kersting, M. ; Knopff, A. ; Koletzko, S. ; Peplow, C. ; Roth, R. ; Stock, J. ; Strauss, E. ; Warncke, K. ; Winkler, C.)

Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study.

Diabetes Metab. Res. Rev. 30, 424-434 (2014)
Postprint Manuscript DOI PMC
Open Access Green
Aims The Environmental Determinants of Diabetes in the Young (TEDDY) planned biomarker discovery studies on longitudinal samples for persistent confirmed islet cell autoantibodies and type 1 diabetes (T1D) using dietary biomarkers, metabolomics, microbiome/viral metagenomics and gene expression. Methods This paper describes the details of planning the TEDDY biomarker discovery studies using a nested case-control design that was chosen as an alternative to the full cohort analysis. In the frame of a nested case-control design, it guides the choice of matching factors, selection of controls, preparation of external quality control samples, and reduction of batch effects along with proper sample allocation. Results and Conclusion Our design is to reduce potential bias and retain study power while reduce the costs by limiting the numbers of samples requiring laboratory analyses. It also covers two primary end points (the occurrence of diabetes-related autoantibodies and the diagnosis of T1D). The resulting list of case-control matched samples for each laboratory was augmented with external quality control (QC) samples.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Batch Effects ; Biomarker Discovery ; Nested Case-control Design ; Teddy ; Type 1 Diabetes; Cohort; Selection; Options
Sprache
Veröffentlichungsjahr 2014
HGF-Berichtsjahr 2014
ISSN (print) / ISBN 1520-7552
e-ISSN 1520-7560
Zeitschrift Diabetes/Metabolism Research and Reviews
Quellenangaben Band: 30, Heft: 5, Seiten: 424-434 Artikelnummer: , Supplement: ,
Verlag Wiley
Verlagsort Hoboken
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Diabetes Research (IDF)
Institute of Diabetes and Obesity (IDO)
Institute of Pancreatic Islet Research (IPI)
POF Topic(s) 30201 - Metabolic Health
30502 - Diabetes: Pathophysiology, Prevention and Therapy
Forschungsfeld(er) Helmholtz Diabetes Center
PSP-Element(e) G-502100-001
G-502290-001
DOI 10.1002/dmrr.2510
WOS ID WOS:000339416900009
Scopus ID 84903691108
PubMed ID 24339168
Erfassungsdatum 2014-01-20
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