To establish the reference range of glycated hemoglobin

Abstract

INTRODUCTION Diabetes Mellitus Worldwide projections suggest that more than 220 million people will have diabetes mellitus by the year 2010, and the majority of these, approximately 213 million, will have type 2 diabetes. 1 Type 2 diabetes mellitus is associated with increased cardiovascular and overall mortality. In fact, type 2 diabetic patients diagnosed before 70 years of age, have only 70% of the life expectancy of non-diabetic people. 2, 3 The long-term relatively specific effects of diabetes include development of retinopathy, nephropathy and neuropathy. 4 People with diabetes are also at increased risk of cardiac, peripheral arterial and cerebrovascular disease. 5 Glycated hemoglobin Glycohaemoglobin is formed by a non-enzymatic interaction between glucose and the amino groups of the valine and lysine residues in haemoglobin. Formation of glycohaemoglobin is irreversible and the level in the red blood cell depends on the blood glucose concentration. Thus, measurement of glycohaemoglobin, which was first introduced in the 1970's, provides a measurement of glycemic control over time, which has been proven to evoke changes in diabetes treatment resulting in improved metabolic control. It is now accepted as a ABSTRACT Background: Diabetes mellitus (DM) has emerged as a major healthcare problem in India. There were an estimated 40 million persons with DM in India in 2007 and this number is predicted to rise to almost 70 million by 2025. It is estimated that every fifth person with diabetes will be an Indian. The objective of the present investigation was to establish the reference range for glycated hemoglobin (HbA1C) in healthy non-diabetic subjects in our hospital laboratory and compare it with the values reported by standard laboratories. Methods: The study was conducted in the Department of Biochemistry, MMIMSR, Mullana (Ambala, Haryana). Total number of subjects was 50 (25 males, 25 females), aged 30 to 70 years. 2 ml of blood was collected from antecubital vein under aseptic conditions from each subject and put in EDTA vials. Hemolysed blood was estimated by semiautoanalyzer for HbA1C. Results: In females, the levels were 6.50 ± 0.74 % while in males the levels were 6.27 ± 0.94 %. The overall range in females was 4.8-7.56 % while in males it was 4.2 to 7.56 %. The values were comparable (p>0.05) with those reported by standard laboratories, e.g. Dr. Lal PathLabs (<6%), Charak diagnostic (4.5-6.3%) and Mayo Clinic (6.5-7%). Conclusion: Our laboratory levels of HbA1C are comparable with the reference range of different laboratories and hence suitable to be used as cutoffs while interpreting the results of patients with DM.