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, Mary Ellen 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

14 Citations (Scopus)

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 - Jul 2014

Fingerprint

Type 1 Diabetes Mellitus
Biomarkers
Quality Control
Autoantibodies
Metagenomics
Metabolomics
Viral Genes
Microbiota
Islets of Langerhans
Longitudinal Studies
Cohort Studies
Gene Expression
Costs and Cost Analysis

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study. / Lee, Hye Seung; Burkhardt, Brant R.; Mcleod, Wendy; Smith, Susan; Eberhard, Chris; Lynch, Kristian; Hadley, David; Rewers, Marian; Simell, Olli; She, Jin Xiong; Hagopian, Bill; Lernmark, Ake; Akolkar, Beena; Ziegler, Anette G.; Krischer, Jeffrey P.; Barriga, Katherine; Bautista, Kimberly; Baxter, Judith; Eisenbarth, George; Frank, Nicole; Gesualdo, Patricia; Hoffman, Michelle; Ide, Lisa; Karban, Rachel; Liu, Edwin; Norris, Jill; Waugh, Kathleen; Samper-Imaz, Adela; Steck, Andrea; Schatz, Desmond; Hopkins, Diane; Steed, Leigh; Thomas, Jamie; Silvis, Katherine; Haller, Michael; Shankar, Meena; Sheehan, Eleni; Gardiner, Melissa; McIndoe, Richard; Liu, Haitao; Nechtman, John; Sharma, Ashok; Williams, Joshua; Foghis, Gabriela; Anderson W., Stephen W.; Beyerlein, Andreas; Bonifacio, Ezio; Hummel, Michael; Hummel, Sandra; Foterek, Kristina; Kersting, Mathilde; Knopff, Annette; Koletzko, Sibylle; Peplow, Claudia; Roth, Roswith; Schenke, Julia; Stock, Joanna; Strauss, Elisabeth; Warncke, Katharina; Winkler, Christiane; Simell G., Olli G.; Hyoty, Heikki; Ilonen, Jorma; Knip, Mikael; Koivu, Annika; Koreasalo, Mirva; Kahonen, Miia; Lonnrot, Maria; Multasuo, Katja; Mantymaki, Elina; Mykkanen, Juha; Nanto-Salonen, Kirsti; Niininen, Tiina; Nyblom, Mia; Rautanen, Jenna; Riikonen, Anne; Romo, Minna; Simell, Aaro; Simell, Barbara; Simell, Tuula; Simell, Ville; Sjoberg, Maija; Stenius, Aino; Toppari, Jorma; Varjonen, Eeva; Veijola, Riitta; Virtanen M., Suvi M.; Akerlund, Mari; Agardh, Daniel; Andrén-Aronsson, Carin; Ask, Maria; Bremer, Jenny; Carlsson, Ulla Marie; Cilio, Corrado; Ericson-Hallstrom, Emilie; Fransson, Lina; Gard, Thomas; Gerardsson, Joanna; Hakansson, Rasmus; Hansen, Monica; Hansson, Gertie; Hyberg, Susanne; Johansen, Fredrik; Jonasdottir, Berglind; Jonsson, Linda; Larsson, Helena; Lernmark, Barbro; Mansson-Martinez, Maria; Markan, Maria; Massadakis, Theodosia; Melin, Jessica; Mestan, Zeliha; Nilsson, Anita; Nilsson, Emma; Rahmati, Kobra; Rosenquist, Anna; Salami, Falastin; Jarvirova, Monica Sedig; Sibthorpe, Sara; Sjoberg, Birgitta; Swartling, Ulrica; Trulsson, Erika; Torn, Carina; Wallin, Anne; Wimar, Asa; Aberg, Sofie; Hagopian A., William A.; Yan, Xiang; Killian, Michael; Crouch, Claire Cowen; Hay M., Kristen M.; Ayres, Stephen; Adams, Carissa; Bratrude, Brandi; Coughlin, David; Fowler, Greer; Franco, Czarina; Hammar, Carla; Heaney, Diana; Marcus, Patrick; Meyer, Arlene; Mulenga, Denise; Scott, Elizabeth; Skidmore, Jennifer; Stabbert, Joshua; Stepitova, Viktoria; Williams, Nancy; Becker, Dorothy; Franciscus, Margaret; Dalmagro-Elias, Mary Ellen; Daftary, Ashi; Klein, Mary Beth; Abbondondolo, Michael; Austin-Gonzalez, Sarah; Brown, Rasheedah; Burkhardt, Brant; Butterworth, Martha; Cuthbertson, David; Eberhard, Christopher; Fiske, Steven; Gowda, Veena; Lane, Page; Liu, Shu; Liu, Xiang; Malloy, Jamie; McCarthy, Cristina; McLeod, Wendy; Smith, Laura; Tamura, Roy; Uusitalo, Ulla; Vehik, Kendra; Washington, Earnest; Yang, Jimin; Bourcier, Kasia; Briese, Thomas; Johnson, Suzanne Bennett; Oberste, Steve; Triplett, Eric; Yu, Liping; Miao, Dongmei; Bingley, Polly; Williams, Alistair; Chandler, Kyla; Rokni, Saba; Long, Anna; Boldison, Joanna; Butterly, Jacob; Broadhurst, Jessica; Carreno, Gabriella; Curnock, Rachel; Easton, Peter; Geoghan, Ivey; Goode, Julia; Pearson, James; Reed, Charles; Ridewood, Sophie; Wyatt, Rebecca; Eriksson, Elisabeth Aardal; Karlsson, Ewa Lonn; Erlund, Iris; Salminen, Irma; Sundvall, Jouko; Leiviska, Jaana; Lehtonen, Mari; Little R., Randie R.; Tennill L., Alethea L.; Erlich, Henry; Bugawan, Teodorica; Alejandrino, Maria; Fiehn, Oliver; Wikoff, Bill; Kind, Tobias; Palazoglu, Mine; Wong, Joyce; Wohlgemuth, Gert; Petrosino F., Joseph F.; Marcovina M., Santica M.; Higgins, Heather; Ke, Sandra; Zhao, Yansheng; Jiang, Na; Rich S., Stephen S.; Chen, Wei Min; Onengut-Gumuscu, Suna; Farber, Emily; Pickin, Rebecca Roche; Davis, Jordan; Gallo, Dan.

In: Diabetes/Metabolism Research and Reviews, Vol. 30, No. 5, 07.2014, p. 424-434.

Research output: Contribution to journalArticle

Lee, HS, Burkhardt, BR, Mcleod, W, Smith, S, Eberhard, C, Lynch, K, Hadley, D, Rewers, M, Simell, O, She, JX, Hagopian, B, Lernmark, A, Akolkar, B, Ziegler, AG, Krischer, JP, Barriga, K, Bautista, K, Baxter, J, Eisenbarth, G, Frank, N, Gesualdo, P, Hoffman, M, Ide, L, Karban, R, Liu, E, Norris, J, Waugh, K, Samper-Imaz, A, Steck, A, Schatz, D, Hopkins, D, Steed, L, Thomas, J, Silvis, K, Haller, M, Shankar, M, Sheehan, E, Gardiner, M, McIndoe, R, Liu, H, Nechtman, J, Sharma, A, Williams, J, Foghis, G, Anderson W., SW, Beyerlein, A, Bonifacio, E, Hummel, M, Hummel, S, Foterek, K, Kersting, M, Knopff, A, Koletzko, S, Peplow, C, Roth, R, Schenke, J, Stock, J, Strauss, E, Warncke, K, Winkler, C, Simell G., OG, Hyoty, H, Ilonen, J, Knip, M, Koivu, A, Koreasalo, M, Kahonen, M, Lonnrot, M, Multasuo, K, Mantymaki, E, Mykkanen, J, Nanto-Salonen, K, Niininen, T, Nyblom, M, Rautanen, J, Riikonen, A, Romo, M, Simell, A, Simell, B, Simell, T, Simell, V, Sjoberg, M, Stenius, A, Toppari, J, Varjonen, E, Veijola, R, Virtanen M., SM, Akerlund, M, Agardh, D, Andrén-Aronsson, C, Ask, M, Bremer, J, Carlsson, UM, Cilio, C, Ericson-Hallstrom, E, Fransson, L, Gard, T, Gerardsson, J, Hakansson, R, Hansen, M, Hansson, G, Hyberg, S, Johansen, F, Jonasdottir, B, Jonsson, L, Larsson, H, Lernmark, B, Mansson-Martinez, M, Markan, M, Massadakis, T, Melin, J, Mestan, Z, Nilsson, A, Nilsson, E, Rahmati, K, Rosenquist, A, Salami, F, Jarvirova, MS, Sibthorpe, S, Sjoberg, B, Swartling, U, Trulsson, E, Torn, C, Wallin, A, Wimar, A, Aberg, S, Hagopian A., WA, Yan, X, Killian, M, Crouch, CC, Hay M., KM, Ayres, S, Adams, C, Bratrude, B, Coughlin, D, Fowler, G, Franco, C, Hammar, C, Heaney, D, Marcus, P, Meyer, A, Mulenga, D, Scott, E, Skidmore, J, Stabbert, J, Stepitova, V, Williams, N, Becker, D, Franciscus, M, Dalmagro-Elias, ME, Daftary, A, Klein, MB, Abbondondolo, M, Austin-Gonzalez, S, Brown, R, Burkhardt, B, Butterworth, M, Cuthbertson, D, Eberhard, C, Fiske, S, Gowda, V, Lane, P, Liu, S, Liu, X, Malloy, J, McCarthy, C, McLeod, W, Smith, L, Tamura, R, Uusitalo, U, Vehik, K, Washington, E, Yang, J, Bourcier, K, Briese, T, Johnson, SB, Oberste, S, Triplett, E, Yu, L, Miao, D, Bingley, P, Williams, A, Chandler, K, Rokni, S, Long, A, Boldison, J, Butterly, J, Broadhurst, J, Carreno, G, Curnock, R, Easton, P, Geoghan, I, Goode, J, Pearson, J, Reed, C, Ridewood, S, Wyatt, R, Eriksson, EA, Karlsson, EL, Erlund, I, Salminen, I, Sundvall, J, Leiviska, J, Lehtonen, M, Little R., RR, Tennill L., AL, Erlich, H, Bugawan, T, Alejandrino, M, Fiehn, O, Wikoff, B, Kind, T, Palazoglu, M, Wong, J, Wohlgemuth, G, Petrosino F., JF, Marcovina M., SM, Higgins, H, Ke, S, Zhao, Y, Jiang, N, Rich S., SS, Chen, WM, Onengut-Gumuscu, S, Farber, E, Pickin, RR, Davis, J & 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, vol. 30, no. 5, pp. 424-434. https://doi.org/10.1002/dmrr.2510
Lee, Hye Seung ; Burkhardt, Brant R. ; Mcleod, Wendy ; Smith, Susan ; Eberhard, Chris ; Lynch, Kristian ; Hadley, David ; Rewers, Marian ; Simell, Olli ; She, Jin Xiong ; Hagopian, Bill ; Lernmark, Ake ; Akolkar, Beena ; Ziegler, Anette G. ; Krischer, Jeffrey P. ; Barriga, Katherine ; Bautista, Kimberly ; Baxter, Judith ; Eisenbarth, George ; Frank, Nicole ; Gesualdo, Patricia ; Hoffman, Michelle ; Ide, Lisa ; Karban, Rachel ; Liu, Edwin ; Norris, Jill ; Waugh, Kathleen ; Samper-Imaz, Adela ; Steck, Andrea ; Schatz, Desmond ; Hopkins, Diane ; Steed, Leigh ; Thomas, Jamie ; Silvis, Katherine ; Haller, Michael ; Shankar, Meena ; Sheehan, Eleni ; Gardiner, Melissa ; McIndoe, Richard ; Liu, Haitao ; Nechtman, John ; Sharma, Ashok ; Williams, Joshua ; Foghis, Gabriela ; Anderson W., Stephen W. ; Beyerlein, Andreas ; Bonifacio, Ezio ; Hummel, Michael ; Hummel, Sandra ; Foterek, Kristina ; Kersting, Mathilde ; Knopff, Annette ; Koletzko, Sibylle ; Peplow, Claudia ; Roth, Roswith ; Schenke, Julia ; Stock, Joanna ; Strauss, Elisabeth ; Warncke, Katharina ; Winkler, Christiane ; Simell G., Olli G. ; Hyoty, Heikki ; Ilonen, Jorma ; Knip, Mikael ; Koivu, Annika ; Koreasalo, Mirva ; Kahonen, Miia ; Lonnrot, Maria ; Multasuo, Katja ; Mantymaki, Elina ; Mykkanen, Juha ; Nanto-Salonen, Kirsti ; Niininen, Tiina ; Nyblom, Mia ; Rautanen, Jenna ; Riikonen, Anne ; Romo, Minna ; Simell, Aaro ; Simell, Barbara ; Simell, Tuula ; Simell, Ville ; Sjoberg, Maija ; Stenius, Aino ; Toppari, Jorma ; Varjonen, Eeva ; Veijola, Riitta ; Virtanen M., Suvi M. ; Akerlund, Mari ; Agardh, Daniel ; Andrén-Aronsson, Carin ; Ask, Maria ; Bremer, Jenny ; Carlsson, Ulla Marie ; Cilio, Corrado ; Ericson-Hallstrom, Emilie ; Fransson, Lina ; Gard, Thomas ; Gerardsson, Joanna ; Hakansson, Rasmus ; Hansen, Monica ; Hansson, Gertie ; Hyberg, Susanne ; Johansen, Fredrik ; Jonasdottir, Berglind ; Jonsson, Linda ; Larsson, Helena ; Lernmark, Barbro ; Mansson-Martinez, Maria ; Markan, Maria ; Massadakis, Theodosia ; Melin, Jessica ; Mestan, Zeliha ; Nilsson, Anita ; Nilsson, Emma ; Rahmati, Kobra ; Rosenquist, Anna ; Salami, Falastin ; Jarvirova, Monica Sedig ; Sibthorpe, Sara ; Sjoberg, Birgitta ; Swartling, Ulrica ; Trulsson, Erika ; Torn, Carina ; Wallin, Anne ; Wimar, Asa ; Aberg, Sofie ; Hagopian A., William A. ; Yan, Xiang ; Killian, Michael ; Crouch, Claire Cowen ; Hay M., Kristen M. ; Ayres, Stephen ; Adams, Carissa ; Bratrude, Brandi ; Coughlin, David ; Fowler, Greer ; Franco, Czarina ; Hammar, Carla ; Heaney, Diana ; Marcus, Patrick ; Meyer, Arlene ; Mulenga, Denise ; Scott, Elizabeth ; Skidmore, Jennifer ; Stabbert, Joshua ; Stepitova, Viktoria ; Williams, Nancy ; Becker, Dorothy ; Franciscus, Margaret ; Dalmagro-Elias, Mary Ellen ; Daftary, Ashi ; Klein, Mary Beth ; Abbondondolo, Michael ; Austin-Gonzalez, Sarah ; Brown, Rasheedah ; Burkhardt, Brant ; Butterworth, Martha ; Cuthbertson, David ; Eberhard, Christopher ; Fiske, Steven ; Gowda, Veena ; Lane, Page ; Liu, Shu ; Liu, Xiang ; Malloy, Jamie ; McCarthy, Cristina ; McLeod, Wendy ; Smith, Laura ; Tamura, Roy ; Uusitalo, Ulla ; Vehik, Kendra ; Washington, Earnest ; Yang, Jimin ; Bourcier, Kasia ; Briese, Thomas ; Johnson, Suzanne Bennett ; Oberste, Steve ; Triplett, Eric ; Yu, Liping ; Miao, Dongmei ; Bingley, Polly ; Williams, Alistair ; Chandler, Kyla ; Rokni, Saba ; Long, Anna ; Boldison, Joanna ; Butterly, Jacob ; Broadhurst, Jessica ; Carreno, Gabriella ; Curnock, Rachel ; Easton, Peter ; Geoghan, Ivey ; Goode, Julia ; Pearson, James ; Reed, Charles ; Ridewood, Sophie ; Wyatt, Rebecca ; Eriksson, Elisabeth Aardal ; Karlsson, Ewa Lonn ; Erlund, Iris ; Salminen, Irma ; Sundvall, Jouko ; Leiviska, Jaana ; Lehtonen, Mari ; Little R., Randie R. ; Tennill L., Alethea L. ; Erlich, Henry ; Bugawan, Teodorica ; Alejandrino, Maria ; Fiehn, Oliver ; Wikoff, Bill ; Kind, Tobias ; Palazoglu, Mine ; Wong, Joyce ; Wohlgemuth, Gert ; Petrosino F., Joseph F. ; Marcovina M., Santica M. ; Higgins, Heather ; Ke, Sandra ; Zhao, Yansheng ; Jiang, Na ; Rich S., Stephen S. ; Chen, Wei Min ; Onengut-Gumuscu, Suna ; Farber, Emily ; Pickin, Rebecca Roche ; Davis, Jordan ; Gallo, Dan. / Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study. In: Diabetes/Metabolism Research and Reviews. 2014 ; Vol. 30, No. 5. pp. 424-434.
@article{94adf71eefcf4a6e9e3059c043f31cc5,
title = "Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study",
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.",
keywords = "Batch effects, Biomarker discovery, Nested case-control design, TEDDY, Type 1 diabetes",
author = "Lee, {Hye Seung} and Burkhardt, {Brant R.} and Wendy Mcleod and Susan Smith and Chris Eberhard and Kristian Lynch and David Hadley and Marian Rewers and Olli Simell and She, {Jin Xiong} and Bill Hagopian and Ake Lernmark and Beena Akolkar and Ziegler, {Anette G.} and Krischer, {Jeffrey P.} and Katherine Barriga and Kimberly Bautista and Judith Baxter and George Eisenbarth and Nicole Frank and Patricia Gesualdo and Michelle Hoffman and Lisa Ide and Rachel Karban and Edwin Liu and Jill Norris and Kathleen Waugh and Adela Samper-Imaz and Andrea Steck and Desmond Schatz and Diane Hopkins and Leigh Steed and Jamie Thomas and Katherine Silvis and Michael Haller and Meena Shankar and Eleni Sheehan and Melissa Gardiner and Richard McIndoe and Haitao Liu and John Nechtman and Ashok Sharma and Joshua Williams and Gabriela Foghis and {Anderson W.}, {Stephen W.} and Andreas Beyerlein and Ezio Bonifacio and Michael Hummel and Sandra Hummel and Kristina Foterek and Mathilde Kersting and Annette Knopff and Sibylle Koletzko and Claudia Peplow and Roswith Roth and Julia Schenke and Joanna Stock and Elisabeth Strauss and Katharina Warncke and Christiane Winkler and {Simell G.}, {Olli G.} and Heikki Hyoty and Jorma Ilonen and Mikael Knip and Annika Koivu and Mirva Koreasalo and Miia Kahonen and Maria Lonnrot and Katja Multasuo and Elina Mantymaki and Juha Mykkanen and Kirsti Nanto-Salonen and Tiina Niininen and Mia Nyblom and Jenna Rautanen and Anne Riikonen and Minna Romo and Aaro Simell and Barbara Simell and Tuula Simell and Ville Simell and Maija Sjoberg and Aino Stenius and Jorma Toppari and Eeva Varjonen and Riitta Veijola and {Virtanen M.}, {Suvi M.} and Mari Akerlund and Daniel Agardh and Carin Andr{\'e}n-Aronsson and Maria Ask and Jenny Bremer and Carlsson, {Ulla Marie} and Corrado Cilio and Emilie Ericson-Hallstrom and Lina Fransson and Thomas Gard and Joanna Gerardsson and Rasmus Hakansson and Monica Hansen and Gertie Hansson and Susanne Hyberg and Fredrik Johansen and Berglind Jonasdottir and Linda Jonsson and Helena Larsson and Barbro Lernmark and Maria Mansson-Martinez and Maria Markan and Theodosia Massadakis and Jessica Melin and Zeliha Mestan and Anita Nilsson and Emma Nilsson and Kobra Rahmati and Anna Rosenquist and Falastin Salami and Jarvirova, {Monica Sedig} and Sara Sibthorpe and Birgitta Sjoberg and Ulrica Swartling and Erika Trulsson and Carina Torn and Anne Wallin and Asa Wimar and Sofie Aberg and {Hagopian A.}, {William A.} and Xiang Yan and Michael Killian and Crouch, {Claire Cowen} and {Hay M.}, {Kristen M.} and Stephen Ayres and Carissa Adams and Brandi Bratrude and David Coughlin and Greer Fowler and Czarina Franco and Carla Hammar and Diana Heaney and Patrick Marcus and Arlene Meyer and Denise Mulenga and Elizabeth Scott and Jennifer Skidmore and Joshua Stabbert and Viktoria Stepitova and Nancy Williams and Dorothy Becker and Margaret Franciscus and Dalmagro-Elias, {Mary Ellen} and Ashi Daftary and Klein, {Mary Beth} and Michael Abbondondolo and Sarah Austin-Gonzalez and Rasheedah Brown and Brant Burkhardt and Martha Butterworth and David Cuthbertson and Christopher Eberhard and Steven Fiske and Veena Gowda and Page Lane and Shu Liu and Xiang Liu and Jamie Malloy and Cristina McCarthy and Wendy McLeod and Laura Smith and Roy Tamura and Ulla Uusitalo and Kendra Vehik and Earnest Washington and Jimin Yang and Kasia Bourcier and Thomas Briese and Johnson, {Suzanne Bennett} and Steve Oberste and Eric Triplett and Liping Yu and Dongmei Miao and Polly Bingley and Alistair Williams and Kyla Chandler and Saba Rokni and Anna Long and Joanna Boldison and Jacob Butterly and Jessica Broadhurst and Gabriella Carreno and Rachel Curnock and Peter Easton and Ivey Geoghan and Julia Goode and James Pearson and Charles Reed and Sophie Ridewood and Rebecca Wyatt and Eriksson, {Elisabeth Aardal} and Karlsson, {Ewa Lonn} and Iris Erlund and Irma Salminen and Jouko Sundvall and Jaana Leiviska and Mari Lehtonen and {Little R.}, {Randie R.} and {Tennill L.}, {Alethea L.} and Henry Erlich and Teodorica Bugawan and Maria Alejandrino and Oliver Fiehn and Bill Wikoff and Tobias Kind and Mine Palazoglu and Joyce Wong and Gert Wohlgemuth and {Petrosino F.}, {Joseph F.} and {Marcovina M.}, {Santica M.} and Heather Higgins and Sandra Ke and Yansheng Zhao and Na Jiang and {Rich S.}, {Stephen S.} and Chen, {Wei Min} and Suna Onengut-Gumuscu and Emily Farber and Pickin, {Rebecca Roche} and Jordan Davis and Dan Gallo",
year = "2014",
month = "7",
doi = "10.1002/dmrr.2510",
language = "English (US)",
volume = "30",
pages = "424--434",
journal = "Diabetes/Metabolism Research and Reviews",
issn = "1520-7552",
publisher = "John Wiley and Sons Ltd",
number = "5",

}

TY - JOUR

T1 - Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study

AU - Lee, Hye Seung

AU - Burkhardt, Brant R.

AU - Mcleod, Wendy

AU - Smith, Susan

AU - Eberhard, Chris

AU - Lynch, Kristian

AU - Hadley, David

AU - Rewers, Marian

AU - Simell, Olli

AU - She, Jin Xiong

AU - Hagopian, Bill

AU - Lernmark, Ake

AU - Akolkar, Beena

AU - Ziegler, Anette G.

AU - Krischer, Jeffrey P.

AU - Barriga, Katherine

AU - Bautista, Kimberly

AU - Baxter, Judith

AU - Eisenbarth, George

AU - Frank, Nicole

AU - Gesualdo, Patricia

AU - Hoffman, Michelle

AU - Ide, Lisa

AU - Karban, Rachel

AU - Liu, Edwin

AU - Norris, Jill

AU - Waugh, Kathleen

AU - Samper-Imaz, Adela

AU - Steck, Andrea

AU - Schatz, Desmond

AU - Hopkins, Diane

AU - Steed, Leigh

AU - Thomas, Jamie

AU - Silvis, Katherine

AU - Haller, Michael

AU - Shankar, Meena

AU - Sheehan, Eleni

AU - Gardiner, Melissa

AU - McIndoe, Richard

AU - Liu, Haitao

AU - Nechtman, John

AU - Sharma, Ashok

AU - Williams, Joshua

AU - Foghis, Gabriela

AU - Anderson W., Stephen W.

AU - Beyerlein, Andreas

AU - Bonifacio, Ezio

AU - Hummel, Michael

AU - Hummel, Sandra

AU - Foterek, Kristina

AU - Kersting, Mathilde

AU - Knopff, Annette

AU - Koletzko, Sibylle

AU - Peplow, Claudia

AU - Roth, Roswith

AU - Schenke, Julia

AU - Stock, Joanna

AU - Strauss, Elisabeth

AU - Warncke, Katharina

AU - Winkler, Christiane

AU - Simell G., Olli G.

AU - Hyoty, Heikki

AU - Ilonen, Jorma

AU - Knip, Mikael

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AU - Koreasalo, Mirva

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AU - Lonnrot, Maria

AU - Multasuo, Katja

AU - Mantymaki, Elina

AU - Mykkanen, Juha

AU - Nanto-Salonen, Kirsti

AU - Niininen, Tiina

AU - Nyblom, Mia

AU - Rautanen, Jenna

AU - Riikonen, Anne

AU - Romo, Minna

AU - Simell, Aaro

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AU - Simell, Tuula

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AU - Ericson-Hallstrom, Emilie

AU - Fransson, Lina

AU - Gard, Thomas

AU - Gerardsson, Joanna

AU - Hakansson, Rasmus

AU - Hansen, Monica

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AU - Melin, Jessica

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AU - Nilsson, Anita

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AU - Rahmati, Kobra

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AU - Sibthorpe, Sara

AU - Sjoberg, Birgitta

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AU - Oberste, Steve

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AU - Williams, Alistair

AU - Chandler, Kyla

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AU - Butterly, Jacob

AU - Broadhurst, Jessica

AU - Carreno, Gabriella

AU - Curnock, Rachel

AU - Easton, Peter

AU - Geoghan, Ivey

AU - Goode, Julia

AU - Pearson, James

AU - Reed, Charles

AU - Ridewood, Sophie

AU - Wyatt, Rebecca

AU - Eriksson, Elisabeth Aardal

AU - Karlsson, Ewa Lonn

AU - Erlund, Iris

AU - Salminen, Irma

AU - Sundvall, Jouko

AU - Leiviska, Jaana

AU - Lehtonen, Mari

AU - Little R., Randie R.

AU - Tennill L., Alethea L.

AU - Erlich, Henry

AU - Bugawan, Teodorica

AU - Alejandrino, Maria

AU - Fiehn, Oliver

AU - Wikoff, Bill

AU - Kind, Tobias

AU - Palazoglu, Mine

AU - Wong, Joyce

AU - Wohlgemuth, Gert

AU - Petrosino F., Joseph F.

AU - Marcovina M., Santica M.

AU - Higgins, Heather

AU - Ke, Sandra

AU - Zhao, Yansheng

AU - Jiang, Na

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AU - Chen, Wei Min

AU - Onengut-Gumuscu, Suna

AU - Farber, Emily

AU - Pickin, Rebecca Roche

AU - Davis, Jordan

AU - Gallo, Dan

PY - 2014/7

Y1 - 2014/7

N2 - 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.

AB - 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.

KW - Batch effects

KW - Biomarker discovery

KW - Nested case-control design

KW - TEDDY

KW - Type 1 diabetes

UR - http://www.scopus.com/inward/record.url?scp=84903691108&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84903691108&partnerID=8YFLogxK

U2 - 10.1002/dmrr.2510

DO - 10.1002/dmrr.2510

M3 - Article

C2 - 24339168

AN - SCOPUS:84903691108

VL - 30

SP - 424

EP - 434

JO - Diabetes/Metabolism Research and Reviews

JF - Diabetes/Metabolism Research and Reviews

SN - 1520-7552

IS - 5

ER -