Cross-sectional study of glycosylated haemoglobin in type 2 diabetes mellitus patients of South Indian origin
Keywords:Diabetes, HbA1c, Cut off, South Indian population, Fasting plasma glucose
Background: Prevalence of Type 2 Diabetes Mellitus in Indian population is on rise and is leading to significant morbidity and mortality. The revised ADA guidelines since 2010 have suggested glycated haemoglobin (HbA1c) as a diagnostic test for Type 2 diabetes. HbA1c level is having geographic and ethnic variability independent of glycaemic status and this has not been extensively studied in many regions.
Objective: To study the characteristics of HbA1C in the South Indian population and to determine the cut off value for HbA1C in diagnosing Diabetes in them.
Methods: This is a hospital based observational study conducted at a Tertiary care centre in North Kerala. Patients with age ≥30yrs with Fasting Plasma Glucose (FPG) ≥ 100 or Random Plasma Glucose (RPG) ≥ 200 with symptoms of hyperglycaemia with no previous history of anti diabetic treatment were selected for the study. A preset questionnaire was used to collect the data which was later analysed using relevant statistical techniques.
Results: Out of the consecutive diabetic patients attending medicine OPD 99 newly detected diabetics/prediabetics who were not under any anti diabetic medications were studied. New onset diabetes/prediabetes patients showed
a mean HbA1c of 8.26(SD=2.31). There was no significant correlation of HbA1c values with age, sex and
duration of diabetes in the study population. The HbA1c values also had no significant correlation with systolic blood pressure, total cholesterol values or triglyceride levels. However it was significantly related to Fasting plasma glucose, Post prandial plasma glucose and serum LDL cholesterol values. In newly detected diabetic patients (with FPG≥126 taken as gold standard) ROC analysis determined a HbA1c cut off at 6.45% (AUC=0.76, sensitivity=79%, specificity=60%).
Conclusion: The study provides a reliable cutoff of glycated haemoglobin (6.45%) among South Indian population which is in accordance with the ADA recommendations.
American Diabetes Association. Standards of medical care in diabetes—2013. Diabetes Care 2013;36(Suppl. 1):S11–S66.
Barr RG, Nathan DM, Meigs JB, Singer DE. Tests of glycemia for the diagnosis of type 2 diabetes mellitus. Annal Intern Med 2002; 137:263–272.
McCarter RJ, Hampe JM, Gomez R, Chalew SA. Biological variation in HbA 1c predicts risk of retinopathy and nephropathy in type 1 diabetes. Diabetes Care 2004; 27: 1259–1264.
McCane DR, Hanson RL, Charles MA, Jacobsson LT, Pettitt DJ,Bennett PH et al. Comparison of tests for glycated haemoglobin and fasting and 2-h plasma glucose concentrations as diagnostic methods for diabetes. Br Med J 1994; 308: 1323–1328.
Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ et al. Diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment andcardiovascular disease in patients with type 1 diabetes. Multicenter Study. Randomized Controlled Trial. N Engl J Med 2005; 353:2643–2653.
Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA et al. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. Br Med J 2000; 321: 412–419.
Wiener K, Roberts NB. The relative merits of haemoglobin A 1c and fasting plasma glucose as first-line diagnostic tests for diabetes mellitus in non-pregnant subjects. Diabet Med 1998; 15: 558–563.
Bennett CM, Guo M, Dharmage SC. HbA(1c) as a screening tool for detection of type 2 diabetes: a systematic review. Diabet Med 2007;24(4):333-43.
Jesudason DR, Dunstan K, Leong D, Wittert GA. Macrovascular risk and diagnostic criteria for type 2 diabetes. implications for the use of FPG and HbA 1c for cost-effective screening. Diabetes Care 2003; 26:485–490.
Herdzik E, Safranow K, Ciechanowski K. Diagnostic value of fasting capillary glucose, fructosamine and glycosylated haemoglobin in detecting diabetes and other glucose tolerance abnormalities compared to oral glucose tolerance test. Acta Diabetol 2002;39:15-22.
Ma H, Gao X, Lin HD, Hu Y, Li XM, et al. (2013) Glycated Haemoglobin in Diagnosis of Diabetes Mellitus and Pre-diabetes among Middle-aged and Elderly Population: Shanghai Changfeng Study. Biomed Environ Sci 26: 155–162.
Wan Nazaimoon WM, Md Isa SH, Wan Mohamad WB, Khir AS, Kamaruddin NA, Kamarul IM, Mustafa N, Ismail IS, Ali O, Khalid BA: Prevalence of diabetes in Malaysia and usefulness of HbA1c as a diagnostic criterion. Diabet Med. 2013 Jul;30(7):825-8.
Zhou XH, Ji LN, Luo YY, Zhang XY, Han XY, Qiao Q: Performance of HbA(1c) for detecting newly diagnosed diabetes and pre-diabetes in Chinese communities living in Beijing. Diabet Med. 2009 Dec;26(12):1262-8.
Hu Y, Liu W, Chen Y, Zhang M, Wang L, Zhou H, Wu P, Teng X, Dong Y, Zhou Jw, Xu H, Zheng J, Li S, Tao T, Hu Y, Jia Y: Combined use of fasting plasma glucose and glycated hemoglobin A1c in the screening of diabetes and impaired glucose tolerance. Acta Diabetol. 2010 Sep;47(3):231-6.
Bhowmik B, Diep LM, Munir SB, Rahman M, Wright E, Mahmood S, Afsana F, Ahmed T, Khan AK, Hussain A: HbA(1c) as a diagnostic tool for diabetes and pre-diabetes: the Bangladesh experience. Diabet Med. 2013 Mar;30(3):e70-7.
Akram T. Kharroubi mail, Hisham M. Darwish, Ahmad I. Abu Al-Halaweh, Umaiyeh M. Khammash: Evaluation of Glycated Hemoglobin (HbA1c) for Diagnosing Type 2 Diabetes and Prediabetes among Palestinian Arab Population. Plosone. 2014 Feb; DOI: 10.1371/journal.pone. 0088123.
Hajat C1, Harrison O, Al Siksek Z: Diagnostic testing for diabetes using HbA(1c) in the Abu Dhabi population: Weqaya: the Abu Dhabi cardiovascular screening program. Diabetes Care. 2011 Nov; 34(11):2400-2.
Nair M1, Prabhakaran D, Narayan KM, Sinha R, Lakshmy R, Devasenapathy N, Daniel CR, Gupta R, George PS, Mathew A, Tandon N, Reddy KS: HbA(1c) values for defining diabetes and impaired fasting glucose in Asian Indians. Prim Care Diabetes. 2011 Jul;5(2):95-102.
Ramachandran A1, Snehalatha C, Samith Shetty A, Nanditha A:Predictive value of HbA1c for incident diabetes among subjects with impaired glucose tolerance--analysis of the Indian Diabetes Prevention Programmes. Diabet Med. 2012 Jan; 29(1):94-8.