Establishment of community-based reference intervals for fructosamine, glycated albumin, and 1,5-anhydroglucitol

Elizabeth Selvin, Bethany Warren, Xintong He, David B. Sacks, Amy K Saenger

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60 Scopus citations

Abstract

BACKGROUND: There is growing interest in fructosamine, glycated albumin, and 1,5-anhydroglucitol (1,5-AG) as alternative measures of hyperglycemia, particularly for use in settings where traditional measures (glucose and HbA1c) are problematic or where intermediate (2– 4 weeks) glycemic control is of interest. However, reference intervals for these alternative biomarkers are not established. METHODS: We measured fructosamine, glycated albumin, and 1,5-AG in a community-based sample of US black and white adults who participated in the Atherosclerosis Risk in Communities (ARIC) Study. We calculated reference intervals, evaluated demographic differences, and derived cutoffs aligned with current diagnostic cutpoints for HbA1c and fasting glucose. RESULTS: In a healthy reference population of 1799 individuals (mean age, 55 years; 51% women; 15% black), the 2.5 and 97.5 percentiles, respectively, were 194.8 and 258.0 mol/L for fructosamine, 10.7% and 15.1% for glycated albumin, and 8.4 and 28.7 g/mL for 1,5-AG. Distributions differed by race, sex, and body mass index. Equivalent concentrations of fructosamine and glycated albumin corresponding to an HbA1c of 6.5% (96.5 percentile) were 270.2 mol/L and 15.6%, respectively. Equivalent concentrations of fructosamine and glycated albumin corresponding to a fasting glucose of 126 mg/dL (93.9 percentile) were 261.7 mol/L and 15.0%, respectively. CONCLUSIONS: The reference intervals for these biomarkers should inform their clinical use. Diagnostic cutpoint equivalents for fructosamine and glycated albumin could be useful to identify persons with hyperglycemia in settings where fasting glucose or HbA1c are not available or where the interpretation of these traditional measures is problematic.

Original languageEnglish (US)
Pages (from-to)843-850
Number of pages8
JournalClinical chemistry
Volume64
Issue number5
DOIs
StatePublished - May 2018

Bibliographical note

Funding Information:
E. Selvin, NIH/NIDDK grant K24DK106414; B. Warren, NIH/NHLBI grant T32 HL007024; D.B. Sacks, the Intramural Research Program of the National Institutes of Health Clinical Center. The Atherosclerosis Risk in Communities study has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Department of Health and Human Services, under Contract nos. (HHSN268201700001I, HHSN268201700003I, HHSN268201700005I, HHSN268201700004I, HHSN2682017000021). This work was supported by NIH/NIDDK grant R01DK089174. Reagents for the fructosamine assay were donated by the Roche Diagnostic Corporation. Reagents for the glycated albumin assays were donated by the Asahi Kasei Pharma Corp. Reagents for the 1,5- anhydroglucitol assays were donated by GlycoMark, Inc.

Funding Information:
Employment or Leadership: D.B. Sacks, Clinical Chemistry, AACC. Consultant or Advisory Role: None declared. Stock Ownership: None declared. Honoraria: None declared. Research Funding: E. Selvin, NIH/NIDDK grant K24DK106414; B. Warren, NIH/NHLBI grant T32 HL007024; D.B. Sacks, the Intramural Research Program of the National Institutes of Health Clinical Center. The Atherosclerosis Risk in Communities study has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Department of Health and Human Services, under Contract nos. (HHSN268201700001I, HHSN268201700003I, HHSN268201700005I, HHSN268201700004I, HHSN2682017000021). This work was supported by NIH/NIDDK grant R01DK089174. Reagents for the fruc-tosamine assay were donated by the Roche Diagnostic Corporation. Reagents for the glycated albumin assays were donated by the Asahi Kasei Pharma Corp. Reagents for the 1,5-anhydroglucitol assays were donated by GlycoMark, Inc. Expert Testimony: None declared. Patents: None declared.

Publisher Copyright:
© 2018 American Association for Clinical Chemistry.

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