Chiara Bellia1, Martina Zaninotto2, Chiara Cosma2, Luisa Agnello1, Giulia Bivona1, Mariela Marinova2, Bruna Lo Sasso1, Mario Plebani2, Marcello Ciaccio3. 1. Department of Biopathology and Medical Biotechnologies, Section of Clinical Biochemistry and Clinical Molecular Medicine, University of Palermo, Italy. 2. Department of Laboratory Medicine, University-Hospital, Padova, Italy. 3. Department of Biopathology and Medical Biotechnologies, Section of Clinical Biochemistry and Clinical Molecular Medicine, University of Palermo, Italy; Department of Laboratory Medicine, University-Hospital, Palermo, Italy. Electronic address: marcello.ciaccio@unipa.it.
Abstract
OBJECTIVES: Glycated Albumin (GA) has been proposed as a screening marker for diabetes in Asian countries in the last years. Nevertheless, few studies have been conducted in Caucasian population. The aim of this study is to evaluate the clinical usefulness of GA in diabetes diagnosis in Caucasian asymptomatic subjects considered at risk of diabetes based on medical history and Fasting Plasma Glucose (FPG). DESIGN AND METHODS: Three hundred and thirty-four Caucasian subjects having one or more risk factor for diabetes, and/or FPG ranging from 5.6 mmol/L to 6.9 mmol/L with no symptoms for diabetes were enrolled in this study. Plasma GA was measured by an enzymatic method (quantILab Glycated Albumin) on ILab Taurus instrument (Instrumentation Laboratory - A Werfen Company). RESULTS: GA median levels were 13.2% (IQR:12.2-14.4). Eighteen subjects (5.4%) were classified as diabetics based on their HbA1c. According to the ROC curve analysis, GA identified subjects with diabetes with a sensitivity of 72.2% (95% CI: 46.5-90.3) and a specificity of 71.8% (95% CI: 66.5-76.7) (AUC: 0.80; 95% CI: 0.75-0.84; P < 0.0001) at the cut-off of 14%. The cut-off of 13.5% was associated to a higher sensitivity 88.9% (95%CI: 65.3-98.6) and a specificity of 60.4% (95%CI, 54.8-65.9). CONCLUSIONS: This study confirms the clinical usefulness of GA for the diagnosis of diabetes in Caucasian subjects at risk for diabetes. More studies are required to clarify the role of GA in relation to the other diagnostic criteria for diabetes.
OBJECTIVES: Glycated Albumin (GA) has been proposed as a screening marker for diabetes in Asian countries in the last years. Nevertheless, few studies have been conducted in Caucasian population. The aim of this study is to evaluate the clinical usefulness of GA in diabetes diagnosis in Caucasian asymptomatic subjects considered at risk of diabetes based on medical history and Fasting Plasma Glucose (FPG). DESIGN AND METHODS: Three hundred and thirty-four Caucasian subjects having one or more risk factor for diabetes, and/or FPG ranging from 5.6 mmol/L to 6.9 mmol/L with no symptoms for diabetes were enrolled in this study. Plasma GA was measured by an enzymatic method (quantILab Glycated Albumin) on ILab Taurus instrument (Instrumentation Laboratory - A Werfen Company). RESULTS: GA median levels were 13.2% (IQR:12.2-14.4). Eighteen subjects (5.4%) were classified as diabetics based on their HbA1c. According to the ROC curve analysis, GA identified subjects with diabetes with a sensitivity of 72.2% (95% CI: 46.5-90.3) and a specificity of 71.8% (95% CI: 66.5-76.7) (AUC: 0.80; 95% CI: 0.75-0.84; P < 0.0001) at the cut-off of 14%. The cut-off of 13.5% was associated to a higher sensitivity 88.9% (95%CI: 65.3-98.6) and a specificity of 60.4% (95%CI, 54.8-65.9). CONCLUSIONS: This study confirms the clinical usefulness of GA for the diagnosis of diabetes in Caucasian subjects at risk for diabetes. More studies are required to clarify the role of GA in relation to the other diagnostic criteria for diabetes.