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Glycated hemoglobin in diagnosis of diabetes mellitus and pre-diabetes; validation by oral glucose tolerance test. The Tromsø OGTT Study

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Abstract

Background: Glycated hemoglobin (HbA1c) 6.5% has recently been recommended by the World Health Organization (WHO) and the American Diabetes Association (ADA) as an alternative diagnostic criterion for diabetes mellitus (DM). Aim: To evaluate HbA1c as an alternative to oral glucose tolerance test (OGTT) for diagnosis of DM and pre-diabetes and to find the optimal HbA1c cut-off points for DM and pre-diabetes in our population. Subjects and methods: The subjects were recruited from the Tromsø Study, performed for the 6th time in 2007–2008 with 12,984 participants. All subjects with HbA1c in the range 5.8–6.9% and a random sample of subjects with levels 5.3–5.7% were invited to an OGTT. Results: Among 3476 subjects who completed the OGTT, 199 were diagnosed with DM. The best sensitivity (69.8%) and specificity (81.8%) were found at HbA1c 6.2%. For HbA1c 6.5% we found a sensitivity of 34.7% and specificity 97.1%. The best cut-off points for impaired fasting glucose (no.=314) and impaired glucose tolerance (no.=404) were found at HbA1c 5.9% and 6.0%, respectively. Pre-diabetes detected only by OGTT was associated with worse metabolic characteristics than pre-diabetes detected only by HbA1c. Conclusions: The optimum HbA1c cutoff point for DM in our population was lower than that proposed by WHO and ADA. To establish more precisely the HbA1c levels predictive of micro- and macro-vascular complications, long-term prospective studies are needed. Population-specific optimum cut-off points may be necessary.

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Correspondence to M. S. Hutchinson M.D.

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Hutchinson, M.S., Joakimsen, R.M., Njølstad, I. et al. Glycated hemoglobin in diagnosis of diabetes mellitus and pre-diabetes; validation by oral glucose tolerance test. The Tromsø OGTT Study. J Endocrinol Invest 35, 835–840 (2012). https://doi.org/10.3275/8191

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