Margery A Connelly1, Eke G Gruppen2, Justyna Wolak-Dinsmore3, Steven P Matyus3, Ineke J Riphagen4, Irina Shalaurova3, Stephan J L Bakker4, James D Otvos3, Robin P F Dullaart5. 1. LipoScience, Laboratory Corporation of America® Holdings, Raleigh, NC, United States. Electronic address: connem5@labcorp.com. 2. Department of Endocrinology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands; Department of Nephrology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands. 3. LipoScience, Laboratory Corporation of America® Holdings, Raleigh, NC, United States. 4. Department of Nephrology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands. 5. Department of Endocrinology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.
Abstract
BACKGROUND: GlycA is a recently developed glycoprotein biomarker of systemic inflammation that may be predictive of incident type 2 diabetes mellitus (T2DM). METHODS: Analytical performance of the GlycA test, measured on the Vantera® Clinical Analyzer, was evaluated. To test its prospective association with T2DM, GlycA was measured in 4524 individuals from the PREVEND study and a survival analysis was performed with a mean follow-up period of 7.3y. RESULTS: Imprecision for the GlycA test ranged from 1.3-2.3% and linearity was established between 150 and 1588μmol/l. During the follow-up period, 220 new T2DM cases were ascertained. In analyses adjusted for relevant covariates, GlycA was associated with incident T2DM; hazard ratio (HR) for the highest vs. lowest quartile 1.77 [95% Confidence Interval (CI): 1.10-2.86, P=0.01], whereas the association of high sensitivity C-reactive protein (hsCRP) with T2DM was not significant. GlycA remained associated with incident T2DM after additional adjustment for hsCRP; HR 1.71 [1.00-2.92, P=0.04]. A multivariable adjusted analysis of dichotomized subgroups showed that the hazard for incident T2DM was highest in the subgroup with high GlycA and low hsCRP (P=0.03). CONCLUSIONS: The performance characteristics of the GlycA test reveal that it is suitable for clinical applications, including assessment of the risk of future T2DM.
BACKGROUND: GlycA is a recently developed glycoprotein biomarker of systemic inflammation that may be predictive of incident type 2 diabetes mellitus (T2DM). METHODS: Analytical performance of the GlycA test, measured on the Vantera® Clinical Analyzer, was evaluated. To test its prospective association with T2DM, GlycA was measured in 4524 individuals from the PREVEND study and a survival analysis was performed with a mean follow-up period of 7.3y. RESULTS: Imprecision for the GlycA test ranged from 1.3-2.3% and linearity was established between 150 and 1588μmol/l. During the follow-up period, 220 new T2DM cases were ascertained. In analyses adjusted for relevant covariates, GlycA was associated with incident T2DM; hazard ratio (HR) for the highest vs. lowest quartile 1.77 [95% Confidence Interval (CI): 1.10-2.86, P=0.01], whereas the association of high sensitivity C-reactive protein (hsCRP) with T2DM was not significant. GlycA remained associated with incident T2DM after additional adjustment for hsCRP; HR 1.71 [1.00-2.92, P=0.04]. A multivariable adjusted analysis of dichotomized subgroups showed that the hazard for incident T2DM was highest in the subgroup with high GlycA and low hsCRP (P=0.03). CONCLUSIONS: The performance characteristics of the GlycA test reveal that it is suitable for clinical applications, including assessment of the risk of future T2DM.
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