Definition of the upper reference limit of glycated albumin in blood donors from Italy

Chiara Bellia; Martina Zaninotto; Chiara Cosma; Luisa Agnello; Bruna Lo Sasso; Giulia Bivona; Mario Plebani; Marcello Ciaccio

doi:10.1515/cclm-2017-0179

Article

Definition of the upper reference limit of glycated albumin in blood donors from Italy

Chiara Bellia , Martina Zaninotto , Chiara Cosma , Luisa Agnello , Bruna Lo Sasso , Giulia Bivona , Mario Plebani and Marcello Ciaccio

Published/Copyright: June 6, 2017

Published by

Become an author with De Gruyter Brill

Submit Manuscript Author Information

From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 1

Abstract

Background:

Glycated Albumin (GA) has been proposed as a short-term indicator of glycemic homeostasis. The aim of this study is to describe the distribution of GA in a large sample of blood donors from Italy to evaluate whether demographic features, namely age and sex, could influence GA levels and define specific reference limits.

Methods:

The study included 1334 Italian blood donors. GA was measured using an enzymatic method (quantILab Glycated Albumin, IL Werfen, Germany). The upper reference limit (URL) was calculated using the non-parametric percentile method.

Results:

A modest, although significant, increase of GA was observed in relation to age (p<0.001), especially in males, where the differences were more pronounced (p<0.001 in males, p=0.003 in females). Slight differences were documented based on sex (12% [11.3–12.8] in males; 12.2% [11.4–13.1] in females; p=0.01). After excluding individuals with fasting plasma glucose ≥7 mmol/L, the calculated GA URL was 14.5% (95% CI: 14.3–14.7). Subjects with GA>14.5% presented a mean age of 48.4±12.2 years, 66.7% were males and the mean glucose was 6.88±2.5 mmol/L.

Conclusions:

GA in Caucasians shows a similar increasing trend at older ages documented in other ethnicities. The definition of the URL in this population could be useful for both clinical studies, which will clarify the role of GA for diagnosing and monitoring diabetes, and will encourage the introduction of GA in clinical practice.

Keywords: blood donors; diabetes; glycated albumin; reference limit

Corresponding author: Marcello Ciaccio, MD, PhD, Department of Biopathology and Medical Biotechnologies, Section of Clinical Biochemistry and Clinical Molecular Medicine, University of Palermo, Via del Vespro, 129, 90127 Palermo, Italy, Phone: +39 091 6553296, Fax +39 091 655 3275

aMario Plebani and Marcello Ciaccio are both considered last authors.

Acknowledgments

IL Werfen provided the reagents for GA measurement. The company did not play a role in the study design, collection, analysis and interpretation of data, writing of the manuscript, or in the decision to submit the manuscript for publication.

The authors thank Maddalena Muratore of the Unit of Transfusion Medicine of Villa Sofia-Cervello Hospital and Alessia Pivetti of the Department of Biopathology and Medical Biotechnologies, University of Palermo, for contributing to data collection.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature 2001;414:782–7.10.1038/414782aSearch in Google Scholar PubMed

2. American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care 2017;40:S11–24.10.2337/dc17-S005Search in Google Scholar PubMed

3. American Diabetes Association. Glycemic targets. Diabetes Care 2017;40:S48–56.10.2337/dc17-S009Search in Google Scholar PubMed

4. Ceriello A, Genovese S, Bosi E. The evolving frontier of diabetes therapy: the renaissance of glycemology. Diabetes Res Clin Pract 2016;118:168–71.10.1016/j.diabres.2016.04.036Search in Google Scholar PubMed

5. Yoshiuchi K, Matsuhisa M, Katakami N, Nakatani Y, Sakamoto K, Matsuoka T, et al. Glycated albumin is a better indicator for glucose excursion than glycated hemoglobin in type 1 and type 2 diabetes. Endocr J 2008;55:503–7.10.1507/endocrj.K07E-089Search in Google Scholar PubMed

6. Koga M, Murai J, Morita S, Saito H, Kasayama S. Comparison of annual variability in HbA_1c and glycated albumin in patients with type 1 vs. type 2 diabetes mellitus. J Diabetes Complications 2013;27:211–3.10.1016/j.jdiacomp.2012.12.001Search in Google Scholar PubMed

7. Fukami K, Shibata R, Nakayama H, Yamada K, Okuda S, Koga M. Serum albumin-adjusted glycated albumin reflects glycemic excursion in diabetic patients with severe chronic kidney disease not treated with dialysis. J Diabetes Complications 2015;29:913–7.10.1016/j.jdiacomp.2015.06.003Search in Google Scholar PubMed

8. Danese E, Montagnana M, Nouvenne A, Lippi G. Advantages and pitfalls of fructosamine and glycated albumin in the diagnosis and treatment of diabetes. J Diabetes Sci Technol 2015;9:169–76.10.1177/1932296814567227Search in Google Scholar PubMed PubMed Central

9. Paroni R, Ceriotti F, Galanello R, Battista Leoni G, Panico A, Scurati E, et al. Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma. Clin Biochem 2007;40:1398–405.10.1016/j.clinbiochem.2007.08.001Search in Google Scholar PubMed

10. Takei I, Hoshino T, Tominaga M, Ishibashi M, Kuwa K, Umemoto M, et al. Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry—recommended reference measurement procedure and reference materials for glycated albumin determination. Ann Clin Biochem 2016;53(Pt 1):124–32.10.1177/0004563215599178Search in Google Scholar PubMed

11. Araki T, Ishikawa Y, Okazaki H, Tani Y, Toyooka S, Satake M, et al. Introduction of glycated albumin measurement for all blood donors and the prevalence of a high glycated albumin level in Japan. J Diabetes Investig 2012;3:492–7.10.1111/j.2040-1124.2012.00224.xSearch in Google Scholar

12. Selvin E, Rawlings AM, Grams M, Klein R, Sharrett AR, Steffes M, et al. Fructosamine and glycated albumin for risk stratification and prediction of incident diabetes and microvascular complications: a prospective cohort analysis of the Atherosclerosis Risk in Communities (ARIC) study. Lancet Diabetes Endocrinol 2014;2:279–88.10.1016/S2213-8587(13)70199-2Search in Google Scholar

13. Furusyo N, Koga T, Ai M, Otokozawa S, Kohzuma T, Ikezaki H, et al. Utility of glycated albumin for the diagnosis of diabetes mellitus in a Japanese population study: results from the Kyushu and Okinawa Population Study (KOPS). Diabetologia 2011;54:3028–36.10.1007/s00125-011-2310-6Search in Google Scholar PubMed

14. CLSI. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline, 3rd ed. CLSI document c28-a3. Wayne, PA: Clinical and Laboratory Standards Institute, 2008Search in Google Scholar

15. Montagnana M1, Paleari R, Danese E, Salvagno GL, Lippi G, Guidi GC, et al. Evaluation of biological variation of glycated albumin (GA) and fructosamine in healthy subjects. Clin Chim Acta 2013;423:1–4.10.1016/j.cca.2013.04.003Search in Google Scholar PubMed

16. Chang AM, Halter JB. Aging and insulin secretion. Am J Physiol Endocrinol Metab 2003;284:E7–12.10.1152/ajpendo.00366.2002Search in Google Scholar PubMed

17. DECODE Study Group. Age- and sex-specific prevalences of diabetes and impaired glucose regulation in 13 European cohorts. Diabetes Care 2003;26:61–9.10.2337/diacare.26.1.61Search in Google Scholar PubMed

18. Simard JR, Zunszain PA, Ha CE, Yang JS, Bhagavan NV, Petitpas I, et al. Locating high-affinity fatty acid-binding sites on albumin by x-ray crystallography and NMR spectroscopy. Proc Natl Acad Sci USA 2005;102:17958–63.10.1073/pnas.0506440102Search in Google Scholar PubMed PubMed Central

19. Ueda Y, Matsumoto H. Recent topics in chemical and clinical research on glycated albumin. J Diabetes Sci Technol 2015;9:177–82.10.1177/1932296814567225Search in Google Scholar PubMed PubMed Central

20. Testa R, Ceriotti F, Guerra E, Bonfigli AR, Boemi M, Cucchi M, et al. Glycated albumin: correlation to HbA_1c and preliminary reference interval evaluation. Clin Chem Lab Med 2017;55:e31–3.10.1515/cclm-2016-0512Search in Google Scholar PubMed

Received: 2017-3-1

Accepted: 2017-4-24

Published Online: 2017-6-6

Published in Print: 2017-11-27

You are currently not able to access this content.

Articles in the same Issue

https://doi.org/10.1515/cclm-2017-0179

Keywords for this article

blood donors; diabetes; glycated albumin; reference limit