title: Protocol of an observational study to evaluate diabetic nephropathy through detection of microalbuminuria in Indian patients.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Nephrology, St. Johns Medical College Hospital, Bangalore, India.
authors.lastname: Gokulnath
authors.forename: Manisha
authors.initials: M
authors.lastname: Sahay
authors.forename: Sanjay
authors.initials: S
authors.lastname: Kalra
authors.forename: Vijay
authors.initials: V
authors.lastname: Vishwanathan
authors.forename: Abdul Hamid
authors.initials: AH
authors.lastname: Zargar
authors.forename: Pradeep G
authors.initials: PG
authors.lastname: Talwalkar
authors.forename: Subhash Kuamr
authors.initials: SK
authors.lastname: Wangnoo
authors.forename: Debasish
authors.initials: D
authors.lastname: Maji
authors.forename: G Vijay
authors.initials: GV
authors.lastname: Kumar
authors.forename: Ramesh Kumar
authors.initials: RK
authors.lastname: Sharma
authors.forename: Deodatta
authors.initials: D
authors.lastname: Chafekar
authors.forename: Brij
authors.initials: B
authors.lastname: Mohan
authors.forename: Ganapathi
authors.initials: G
authors.lastname: Bantwal
authors.forename: Anil
authors.initials: A
authors.lastname: Bansali
authors.forename: Jasmeet Singh
authors.initials: JS
authors.lastname: Sahni
keywords: Diabetic nephropathy; India; dipstick test; health policy; microalbuminuria