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

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, Ake Lernmark, Beena Akolkar, Anette G. Ziegler, Jeffrey P. Krischer, Katherine Barriga, Kimberly Bautista, Judith Baxter, George Eisenbarth, Nicole FrankPatricia Gesualdo, Michelle Hoffman, Lisa Ide, Rachel Karban, Edwin Liu, Jill Norris, Kathleen Waugh, Adela Samper-Imaz, Andrea Steck, Desmond Schatz, Diane Hopkins, Leigh Steed, Jamie Thomas, Katherine Silvis, Michael Haller, Meena Shankar, Eleni Sheehan, Melissa Gardiner, Richard McIndoe, Haitao Liu, John Nechtman, Ashok Sharma, Joshua Williams, Gabriela Foghis, Stephen W. Anderson W., Andreas Beyerlein, Ezio Bonifacio, Michael Hummel, Sandra Hummel, Kristina Foterek, Mathilde Kersting, Annette Knopff, Sibylle Koletzko, Claudia Peplow, Roswith Roth, Julia Schenke, Joanna Stock, Elisabeth Strauss, Katharina Warncke, Christiane Winkler, Olli G. Simell G., Heikki Hyoty, Jorma Ilonen, Mikael Knip, Annika Koivu, Mirva Koreasalo, Miia Kahonen, Maria Lonnrot, Katja Multasuo, Elina Mantymaki, Juha Mykkanen, Kirsti Nanto-Salonen, Tiina Niininen, Mia Nyblom, Jenna Rautanen, Anne Riikonen, Minna Romo, Aaro Simell, Barbara Simell, Tuula Simell, Ville Simell, Maija Sjoberg, Aino Stenius, Jorma Toppari, Eeva Varjonen, Riitta Veijola, Suvi M. Virtanen M., Mari Akerlund, Daniel Agardh, Carin Andrén-Aronsson, Maria Ask, Jenny Bremer, Ulla Marie Carlsson, Corrado Cilio, Emilie Ericson-Hallstrom, Lina Fransson, Thomas Gard, Joanna Gerardsson, Rasmus Hakansson, Monica Hansen, Gertie Hansson, Susanne Hyberg, Fredrik Johansen, Berglind Jonasdottir, Linda Jonsson, Helena Larsson, Barbro Lernmark, Maria Mansson-Martinez, Maria Markan, Theodosia Massadakis, Jessica Melin, Zeliha Mestan, Anita Nilsson, Emma Nilsson, Kobra Rahmati, Anna Rosenquist, Falastin Salami, Monica Sedig Jarvirova, Sara Sibthorpe, Birgitta Sjoberg, Ulrica Swartling, Erika Trulsson, Carina Torn, Anne Wallin, Asa Wimar, Sofie Aberg, William A. Hagopian A., Xiang Yan, Michael Killian, Claire Cowen Crouch, Kristen M. Hay M., Stephen Ayres, Carissa Adams, Brandi Bratrude, David Coughlin, Greer Fowler, Czarina Franco, Carla Hammar, Diana Heaney, Patrick Marcus, Arlene Meyer, Denise Mulenga, Elizabeth Scott, Jennifer Skidmore, Joshua Stabbert, Viktoria Stepitova, Nancy Williams, Dorothy Becker, Margaret Franciscus, MaryEllen Dalmagro-Elias, Ashi Daftary, Mary Beth Klein, Michael Abbondondolo, Sarah Austin-Gonzalez, Rasheedah Brown, Brant Burkhardt, Martha Butterworth, David Cuthbertson, Christopher Eberhard, Steven Fiske, Veena Gowda, Page Lane, Shu Liu, Xiang Liu, Jamie Malloy, Cristina McCarthy, Wendy McLeod, Laura Smith, Roy Tamura, Ulla Uusitalo, Kendra Vehik, Earnest Washington, Jimin Yang, Kasia Bourcier, Thomas Briese, Suzanne Bennett Johnson, Steve Oberste, Eric Triplett, Liping Yu, Dongmei Miao, Polly Bingley, Alistair Williams, Kyla Chandler, Saba Rokni, Anna Long, Joanna Boldison, Jacob Butterly, Jessica Broadhurst, Gabriella Carreno, Rachel Curnock, Peter Easton, Ivey Geoghan, Julia Goode, James Pearson, Charles Reed, Sophie Ridewood, Rebecca Wyatt, Elisabeth Aardal Eriksson, Ewa Lonn Karlsson, Iris Erlund, Irma Salminen, Jouko Sundvall, Jaana Leiviska, Mari Lehtonen, Randie R. Little R., Alethea L. Tennill L., Henry Erlich, Teodorica Bugawan, Maria Alejandrino, Oliver Fiehn, Bill Wikoff, Tobias Kind, Mine Palazoglu, Joyce Wong, Gert Wohlgemuth, Joseph F. Petrosino F., Santica M. Marcovina M., Heather Higgins, Sandra Ke, Yansheng Zhao, Na Jiang, Stephen S. Rich S., Wei Min Chen, Suna Onengut-Gumuscu, Emily Farber, Rebecca Roche Pickin, Jordan Davis, Dan Gallo

Research output: Contribution to journalArticle

19 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)424-434
Number of pages11
JournalDiabetes/Metabolism Research and Reviews
Volume30
Issue number5
DOIs
StatePublished - 2014

Keywords

  • Batch effects
  • Biomarker discovery
  • Nested case-control design
  • TEDDY
  • Type 1 diabetes

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine
  • Medicine(all)

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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., Barriga, K., Bautista, K., Baxter, J., Eisenbarth, G., ... Gallo, D. (2014). Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study. Diabetes/Metabolism Research and Reviews, 30(5), 424-434. https://doi.org/10.1002/dmrr.2510