Volume 30, Issue 5 pp. 424-434
Research Article

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

Hye-Seung Lee

Hye-Seung Lee

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

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Brant R. Burkhardt

Brant R. Burkhardt

Department of Cell Biology, Microbiology and Molecular Biology, University of South Florida, Tampa, FL, USA

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Wendy McLeod

Wendy McLeod

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

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Susan Smith

Susan Smith

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

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Chris Eberhard

Chris Eberhard

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

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Kristian Lynch

Kristian Lynch

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

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David Hadley

David Hadley

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

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Marian Rewers

Marian Rewers

Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, USA

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Olli Simell

Olli Simell

Department of Pediatrics, Turku University Central Hospital, Turku, Finland

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Jin-Xiong She

Jin-Xiong She

Center for Biotechnology and Genomic Medicine, Medical College of Georgia, Georgia Regents University, Augusta, GA, USA

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Bill Hagopian

Bill Hagopian

Pacific Northwest Diabetes Research Institute, Seattle, WA, USA

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Ake Lernmark

Ake Lernmark

Department of Clinical Sciences, Lund University, Malmo, Sweden

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Beena Akolkar

Beena Akolkar

National Institute of Diabetes & Digestive & Kidney Disorders, Bethesda, MD, USA

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Anette G. Ziegler

Anette G. Ziegler

Institute of Diabetes Research, Helmholtz Zentrum München, and Klinikum rechts der Isar, Technische Universität München, and Forschergruppe Diabetes e.V. Neuherberg, Germany

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Jeffrey P. Krischer

Corresponding Author

Jeffrey P. Krischer

Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA

Correspondence to: Jeffrey P. Krischer, Pediatrics Epidemiology Center, Department of Pediatrics, University of South Florida, Tampa, FL, USA.

E-mail: [email protected]

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The TEDDY study group
First published: 15 December 2013
Citations: 45

Abstract

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 © 2013 John Wiley & Sons, Ltd.

The full text of this article hosted at iucr.org is unavailable due to technical difficulties.