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Year : 2013  |  Volume : 17  |  Issue : 3  |  Page : 496-504

Protocol of an observational study to evaluate diabetic nephropathy through detection of microalbuminuria in Indian patients

1 Department of Nephrology, St. Johns Medical College Hospital, Bangalore, India
2 Department of Nephrology, Osmania Medical College, Osmania General Hospital, Hyderabad, India
3 Department of Endocrinology, Bharti Hospital and B.R.I.D.E., Karnal, India
4 Department of Diabetology, M.V. Hospital for Diabetes, Chennai, India
5 Department of Endocrinology, Advanced Center for Diabetes and Endocrine Care, Srinagar, India
6 Department of Diabetology, S. L. Raheja Hospital for Diabetes, and All India Institute of Diabetes, Mumbai, India
7 Department of Endocrinology, Apollo Hospital, New Delhi, India
8 Department of Endocrinology, Vivekananda Hospital, Kolkata, India
9 Department of Endocrinology, Apollo Hospital, Chennai, India
10 Department of Nephrology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow, India
11 Department of Nephrology, Dr. V. N. Pawar Medical College, Hospital and Research Center, Nashik, India
12 Consultant Physician and Diabetologist, Departments of Diabetology, Brij Medical Center, Kanpur, India
13 St. Johns Medical College Hospital, Bangalore, India
14 Post Graduate Institute, Chandigarh, India
15 Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India

Correspondence Address:
Department of Nephrology, St. Johns Medical College Hospital, Bangalore - 560 034
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Source of Support: This study is sponsored by Dr Reddy’s Laboratories Ltd., Hyderabad, India. Dr Jasmeet Singh Sahni is an employee of Sponsor Company and is a stakeholder in Dr Reddy’s Laboratories Ltd., by means of salary and stocks. Other authors are the investigators who will be conducting this study and do not have any conflict of interest., Conflict of Interest: None

DOI: 10.4103/2230-8210.111655

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Aim: To assess the prevalence of persistent microalbuminuria (MAU), its clinical correlates by dip stick method, its predictive value for potential kidney disease and the utility of this test as objective cue for health care seeking behavior in adult Indian patients with type 2 diabetes mellitus. Materials and Methods: Approximately 400,000 patients shall be enrolled in this multicentric, cross sectional study. Patients meeting eligibility criteria shall be screened for MAU through urine dipstick test using random daytime single spot urine specimen. Result shall be expressed either positive or negative based on the presence or absence of albumin in the urine and will be correlated with the corresponding random blood glucose. Height, weight, waist circumference and blood pressure shall be assessed. There will be three visits with a minimum interval of 28 days between two visits, to be completed within 180 days, and at least two of three urine tests measured in this period must show elevated albumin levels to diagnose MAU. Conclusion: Detection of MAU through the dipstick method is postulated to be a rapid, reliable test for early detection of diabetic nephropathy, which, in turn will help the physician to plan treatment strategy. Further, it will help to identify the disease burden on the individual and society, and may serve as an objective cue for improved health care seeking behavior, as well as a catalyst for health policy change.

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