Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients

Andrea Mosca; Renata Paleari; Ferruccio Ceriotti; Annunziata Lapolla; Domenico Fedele; Marco Comaschi; Loris Confortin; Carlo Coscelli; Gaetano Crepaldi; Domenico Cucinotta; Giacomo De Ferrari; Pietro Paolo Faronato; Paolo Fumelli; Aldo Galuzzo; Giovanni Ghirlanda; Mario Iorini; Mario Maioli; Valerio Miselli; Stefano Del Prato; Guido Pozza; Fausto Santeusanio; Antonio Tiengo; Mariella Trovati; Claudio Velussi

doi:10.1515/CCLM.2003.188

Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients

Andrea Mosca, Renata Paleari, Ferruccio Ceriotti, Annunziata Lapolla, Domenico Fedele, Marco Comaschi, Loris Confortin, Carlo Coscelli, Gaetano Crepaldi, Domenico Cucinotta, Giacomo De Ferrari, Pietro Paolo Faronato, Paolo Fumelli, Aldo Galuzzo, Giovanni Ghirlanda, Mario Iorini, Mario Maioli, Valerio Miselli, Stefano Del Prato, Guido PozzaFausto Santeusanio, Antonio Tiengo, Mariella Trovati, Claudio Velussi

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article › peer-review

Abstract

The importance of measuring microalbuminuria is well established. However, only scanty data are available concerning the biological variability of albumin excretion in type 2 diabetic subjects. We report our experience from a large clinical trial of a new antihypertensive drug (Lercanidipine) designed to reduce albumin excretion and blood pressure in type 2 diabetic patients with hypertension and microalbuminuria. Eighty seven patients with persistent microalbuminuria were studied within 1 year of the clinical trial. The measurements were performed on blood and timed urine samples frozen at -80°C and shipped to a central laboratory unit. Preliminary experiments were performed to assess albumin stability in urine under various conditions (4°C -20°C and -80°C), particularly with regard to the albumin/creatinine ratio. Urine samples can be stored up to 3 weeks at 4°C or up to 2 months at -80°C. The biological variability of the albumin excretion rate was 25.7%, while that of the albumin/creatinine ratio was 13.4%. These data are useful in defining the analytical goals of imprecision for microalbuminuria (CV = 13% for albumin, and CV = 6% for albumin/creatinine ratio). No correlation between albumin/creatinine ratio and HbA_1c was found in the cohort of 61 microalbuminuric patients who completed the trial. The results of this study confirm that the albumin/creatinine ratio is much more suitable for monitoring albumin excretion in longitudinal studies than the albumin excretion rate.

Original language	English
Pages (from-to)	1229-1233
Number of pages	5
Journal	Clinical Chemistry and Laboratory Medicine
Volume	41
Issue number	9
DOIs	https://doi.org/10.1515/CCLM.2003.188
Publication status	Published - 2003

Keywords

Albuminuria
Biological variability
Diabetes mellitus
Diabetic nephropathy
Glycated hemoglobin
Specimen handling

ASJC Scopus subject areas

Clinical Biochemistry

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10.1515/CCLM.2003.188

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Mosca, A., Paleari, R., Ceriotti, F., Lapolla, A., Fedele, D., Comaschi, M., Confortin, L., Coscelli, C., Crepaldi, G., Cucinotta, D., De Ferrari, G., Faronato, P. P., Fumelli, P., Galuzzo, A., Ghirlanda, G., Iorini, M., Maioli, M., Miselli, V., Del Prato, S., ... Velussi, C. (2003). Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients. Clinical Chemistry and Laboratory Medicine, 41(9), 1229-1233. https://doi.org/10.1515/CCLM.2003.188

Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients. / Mosca, Andrea; Paleari, Renata; Ceriotti, Ferruccio; Lapolla, Annunziata; Fedele, Domenico; Comaschi, Marco; Confortin, Loris; Coscelli, Carlo; Crepaldi, Gaetano; Cucinotta, Domenico; De Ferrari, Giacomo; Faronato, Pietro Paolo; Fumelli, Paolo; Galuzzo, Aldo; Ghirlanda, Giovanni; Iorini, Mario; Maioli, Mario; Miselli, Valerio; Del Prato, Stefano; Pozza, Guido; Santeusanio, Fausto; Tiengo, Antonio; Trovati, Mariella; Velussi, Claudio.

In: Clinical Chemistry and Laboratory Medicine, Vol. 41, No. 9, 2003, p. 1229-1233.

Research output: Contribution to journal › Article › peer-review

Mosca, A, Paleari, R, Ceriotti, F, Lapolla, A, Fedele, D, Comaschi, M, Confortin, L, Coscelli, C, Crepaldi, G, Cucinotta, D, De Ferrari, G, Faronato, PP, Fumelli, P, Galuzzo, A, Ghirlanda, G, Iorini, M, Maioli, M, Miselli, V, Del Prato, S, Pozza, G, Santeusanio, F, Tiengo, A, Trovati, M & Velussi, C 2003, 'Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients', Clinical Chemistry and Laboratory Medicine, vol. 41, no. 9, pp. 1229-1233. https://doi.org/10.1515/CCLM.2003.188

Mosca, Andrea ; Paleari, Renata ; Ceriotti, Ferruccio ; Lapolla, Annunziata ; Fedele, Domenico ; Comaschi, Marco ; Confortin, Loris ; Coscelli, Carlo ; Crepaldi, Gaetano ; Cucinotta, Domenico ; De Ferrari, Giacomo ; Faronato, Pietro Paolo ; Fumelli, Paolo ; Galuzzo, Aldo ; Ghirlanda, Giovanni ; Iorini, Mario ; Maioli, Mario ; Miselli, Valerio ; Del Prato, Stefano ; Pozza, Guido ; Santeusanio, Fausto ; Tiengo, Antonio ; Trovati, Mariella ; Velussi, Claudio. / Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients. In: Clinical Chemistry and Laboratory Medicine. 2003 ; Vol. 41, No. 9. pp. 1229-1233.

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abstract = "The importance of measuring microalbuminuria is well established. However, only scanty data are available concerning the biological variability of albumin excretion in type 2 diabetic subjects. We report our experience from a large clinical trial of a new antihypertensive drug (Lercanidipine) designed to reduce albumin excretion and blood pressure in type 2 diabetic patients with hypertension and microalbuminuria. Eighty seven patients with persistent microalbuminuria were studied within 1 year of the clinical trial. The measurements were performed on blood and timed urine samples frozen at -80°C and shipped to a central laboratory unit. Preliminary experiments were performed to assess albumin stability in urine under various conditions (4°C -20°C and -80°C), particularly with regard to the albumin/creatinine ratio. Urine samples can be stored up to 3 weeks at 4°C or up to 2 months at -80°C. The biological variability of the albumin excretion rate was 25.7%, while that of the albumin/creatinine ratio was 13.4%. These data are useful in defining the analytical goals of imprecision for microalbuminuria (CV = 13% for albumin, and CV = 6% for albumin/creatinine ratio). No correlation between albumin/creatinine ratio and HbA1c was found in the cohort of 61 microalbuminuric patients who completed the trial. The results of this study confirm that the albumin/creatinine ratio is much more suitable for monitoring albumin excretion in longitudinal studies than the albumin excretion rate.",

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AU - Fedele, Domenico

AU - Comaschi, Marco

AU - Confortin, Loris

AU - Coscelli, Carlo

AU - Crepaldi, Gaetano

AU - Cucinotta, Domenico

AU - De Ferrari, Giacomo

AU - Faronato, Pietro Paolo

AU - Fumelli, Paolo

AU - Galuzzo, Aldo

AU - Ghirlanda, Giovanni

AU - Iorini, Mario

AU - Maioli, Mario

AU - Miselli, Valerio

AU - Del Prato, Stefano

AU - Pozza, Guido

AU - Santeusanio, Fausto

AU - Tiengo, Antonio

AU - Trovati, Mariella

AU - Velussi, Claudio

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Biological variability of albumin excretion rate and albumin-to-cretinine ratio in hypertensive type 2 diabetic patients

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