Literature DB >> 24937037

Biomarkers in type 1 diabetes: application to the clinical trial setting.

James E Tooley1, Kevan C Herold.   

Abstract

PURPOSE OF REVIEW: Biomarkers of type 1 diabetes (T1D) are important for assessing risk of developing disease, monitoring disease progression, and determining responses to clinical treatments. Here we review recent advances in the development of biomarkers of T1D with a focus on their utility in clinical trials. RECENT
FINDINGS: Measurements of autoantibodies and metabolic outcomes have been the foundation of monitoring T1D for the past 20 years. Recent advancements have led to improvements in T-cell-specific assays that have been used in large-scale clinical trials to measure antigen-specific T cell responses. Additionally, new tools are being developed for the measurement of β cell mass and death that will allow for more direct measurement of disease activity. Lastly, recent studies have used both immunologic and nonimmunologic biomarkers to identify responders to treatments in clinical trials.
SUMMARY: Use of biomarkers in the study of T1D has largely not changed over the past 20 years; however, recent advancements in the field are establishing new techniques that allow for more precise monitoring of disease progression. These new tools will ultimately lead to an improvement in understanding of disease and will be utilized in clinical trials.

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Year:  2014        PMID: 24937037      PMCID: PMC4163003          DOI: 10.1097/MED.0000000000000076

Source DB:  PubMed          Journal:  Curr Opin Endocrinol Diabetes Obes        ISSN: 1752-296X            Impact factor:   3.243


  54 in total

1.  Detection of β cell death in diabetes using differentially methylated circulating DNA.

Authors:  Eitan M Akirav; Jasmin Lebastchi; Eva M Galvan; Octavian Henegariu; Michael Akirav; Vitaly Ablamunits; Paul M Lizardi; Kevan C Herold
Journal:  Proc Natl Acad Sci U S A       Date:  2011-11-09       Impact factor: 11.205

2.  Large-scale prospective T cell function assays in shipped, unfrozen blood samples: experiences from the multicenter TRIGR trial.

Authors:  David Hadley; Roy K Cheung; Dorothy J Becker; Rose Girgis; Jerry P Palmer; David Cuthbertson; Jeffrey P Krischer; Hans-Michael Dosch
Journal:  Clin Vaccine Immunol       Date:  2013-12-11

3.  Circulating miR-375 as a biomarker of β-cell death and diabetes in mice.

Authors:  Suheda Erener; Majid Mojibian; Jessica K Fox; Heather C Denroche; Timothy J Kieffer
Journal:  Endocrinology       Date:  2013-01-15       Impact factor: 4.736

Review 4.  Type 1 diabetes: translating mechanistic observations into effective clinical outcomes.

Authors:  Kevan C Herold; Dario A A Vignali; Anne Cooke; Jeffrey A Bluestone
Journal:  Nat Rev Immunol       Date:  2013-04       Impact factor: 53.106

5.  Teplizumab treatment may improve C-peptide responses in participants with type 1 diabetes after the new-onset period: a randomised controlled trial.

Authors:  K C Herold; S E Gitelman; S M Willi; P A Gottlieb; F Waldron-Lynch; L Devine; J Sherr; S M Rosenthal; S Adi; M Y Jalaludin; A W Michels; J Dziura; J A Bluestone
Journal:  Diabetologia       Date:  2012-10-21       Impact factor: 10.122

6.  Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders.

Authors:  Kevan C Herold; Stephen E Gitelman; Mario R Ehlers; Peter A Gottlieb; Carla J Greenbaum; William Hagopian; Karen D Boyle; Lynette Keyes-Elstein; Sudeepta Aggarwal; Deborah Phippard; Peter H Sayre; James McNamara; Jeffrey A Bluestone
Journal:  Diabetes       Date:  2013-07-08       Impact factor: 9.461

7.  Teplizumab induces human gut-tropic regulatory cells in humanized mice and patients.

Authors:  Frank Waldron-Lynch; Octavian Henegariu; Songyan Deng; Paula Preston-Hurlburt; James Tooley; Richard Flavell; Kevan C Herold
Journal:  Sci Transl Med       Date:  2012-01-25       Impact factor: 17.956

8.  Islet-specific CTL cloned from a type 1 diabetes patient cause beta-cell destruction after engraftment into HLA-A2 transgenic NOD/scid/IL2RG null mice.

Authors:  Wendy W J Unger; Todd Pearson; Joana R F Abreu; Sandra Laban; Arno R van der Slik; Sacha Mulder-van der Kracht; Michel G D Kester; Dave V Serreze; Leonard D Shultz; Marieke Griffioen; Jan Wouter Drijfhout; Dale L Greiner; Bart O Roep
Journal:  PLoS One       Date:  2012-11-14       Impact factor: 3.240

9.  Immune therapy and β-cell death in type 1 diabetes.

Authors:  Jasmin Lebastchi; Songyan Deng; Amir H Lebastchi; Isabel Beshar; Stephen Gitelman; Steven Willi; Peter Gottlieb; Eitan M Akirav; Jeffrey A Bluestone; Kevan C Herold
Journal:  Diabetes       Date:  2013-02-19       Impact factor: 9.461

10.  Cellular and humoral immune responses in type 1 diabetic patients participating in a phase III GAD-alum intervention trial.

Authors:  Stina Axelsson; Mikael Chéramy; Linda Akerman; Mikael Pihl; Johnny Ludvigsson; Rosaura Casas
Journal:  Diabetes Care       Date:  2013-07-17       Impact factor: 19.112

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  10 in total

1.  A subclass of serum anti-ZnT8 antibodies directed to the surface of live pancreatic β-cells.

Authors:  Chengfeng Merriman; Qiong Huang; Wei Gu; Liping Yu; Dax Fu
Journal:  J Biol Chem       Date:  2017-11-28       Impact factor: 5.157

Review 2.  Immune cell trafficking to the islets during type 1 diabetes.

Authors:  A M Sandor; J Jacobelli; R S Friedman
Journal:  Clin Exp Immunol       Date:  2019-08-30       Impact factor: 4.330

3.  The elusive role of B lymphocytes and islet autoantibodies in (human) type 1 diabetes.

Authors:  Stef J Bloem; Bart O Roep
Journal:  Diabetologia       Date:  2017-04-24       Impact factor: 10.122

Review 4.  Beta cell antigens in type 1 diabetes: triggers in pathogenesis and therapeutic targets.

Authors:  François-Xavier Mauvais; Julien Diana; Peter van Endert
Journal:  F1000Res       Date:  2016-04-22

Review 5.  Translating Mechanism of Regulatory Action of Tolerogenic Dendritic Cells to Monitoring Endpoints in Clinical Trials.

Authors:  Jessica S Suwandi; Tatjana Nikolic; Bart O Roep
Journal:  Front Immunol       Date:  2017-11-22       Impact factor: 7.561

6.  Implication of the intestinal microbiome as a potential surrogate marker of immune responsiveness to experimental therapies in autoimmune diabetes.

Authors:  James C Needell; Charles A Dinarello; Diana Ir; Charles E Robertson; Sarah M Ryan; Miranda E Kroehl; Daniel N Frank; Danny Zipris
Journal:  PLoS One       Date:  2017-03-16       Impact factor: 3.240

Review 7.  The β Cell in Diabetes: Integrating Biomarkers With Functional Measures.

Authors:  Steven E Kahn; Yi-Chun Chen; Nathalie Esser; Austin J Taylor; Daniël H van Raalte; Sakeneh Zraika; C Bruce Verchere
Journal:  Endocr Rev       Date:  2021-09-28       Impact factor: 25.261

8.  Proteomic Analysis of Disease Stratified Human Pancreas Tissue Indicates Unique Signature of Type 1 Diabetes.

Authors:  Tanya C Burch; Margaret A Morris; Martha Campbell-Thompson; Alberto Pugliese; Jerry L Nadler; Julius O Nyalwidhe
Journal:  PLoS One       Date:  2015-08-24       Impact factor: 3.240

Review 9.  Concise Review: Cell-Based Therapies and Other Non-Traditional Approaches for Type 1 Diabetes.

Authors:  Remi J Creusot; Manuela Battaglia; Maria-Grazia Roncarolo; C Garrison Fathman
Journal:  Stem Cells       Date:  2016-02-09       Impact factor: 6.277

Review 10.  Antigen-Specific Regulatory T Cells and Low Dose of IL-2 in Treatment of Type 1 Diabetes.

Authors:  Minh N Pham; Matthias G von Herrath; Jose Luis Vela
Journal:  Front Immunol       Date:  2016-01-11       Impact factor: 7.561

  10 in total

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