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

Author:
  • Hye-Seung Lee
  • Brant R. Burkhardt
  • Wendy McLeod
  • Susan Smith
  • Chris Eberhard
  • Kristian Lynch
  • David Hadley
  • Marian Rewers
  • Olli Simell
  • Jin-Xiong She
  • Bill Hagopian
  • Åke Lernmark
  • Beena Akolkar
  • Anette G. Ziegler
  • Jeffrey P. Krischer
Publishing year: 2014
Language: English
Pages: 424-434
Publication/Series: Diabetes/Metabolism Research Reviews
Volume: 30
Issue: 5
Document type: Journal article
Publisher: John Wiley & Sons

Abstract english

Aims The Environmental Determinants of Diabetes in the Young planned biomarker discovery studies on longitudinal samples for persistent confirmed islet cell autoantibodies and type 1 diabetes using dietary biomarkers, metabolomics, microbiome/viral metagenomics and gene expression. Methods This article describes the details of planning The Environmental Determinants of Diabetes in the Young 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 reducing 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 type 1 diabetes). The resulting list of case-control matched samples for each laboratory was augmented with external quality control samples. Copyright (C) 2013 John Wiley & Sons, Ltd.

Keywords

  • Endocrinology and Diabetes
  • batch effects
  • biomarker discovery
  • nested case-control design
  • TEDDY
  • type 1 diabetes

Other

Published
  • Diabetes and Celiac Unit
  • ISSN: 1520-7552
E-mail: ake [dot] lernmark [at] med [dot] lu [dot] se

Principal investigator

Diabetes and Celiac Unit

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+46 70 616 47 79

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Jan Waldenströms gata 35, Malmö

33

Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12. SE-214 28 Malmö. Telephone: +46 40 39 10 00