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

Abstract

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.

Epidemiology of microvascular complications of diabetes in South Asians and comparison with other ethnicities

“…Prospective data are available from Chennai, south India, where 44% of 152 normoalbuminuric patients with T2DM progressed to proteinuria within 11 years . A large multicenter country‐wide study hoping to enroll 400 000 patients is currently underway to assess the prevalence of MiAU in Indian patients with T2DM …”

“…18 A large multicenter country-wide study hoping to enroll 400 000 patients is currently underway to assess the prevalence of MiAU in Indian patients with T2DM. 37 The differences in prevalence between various studies can be attributed to differences in patient characteristics, such as age and duration of diabetes, as well as the different criteria used to define nephropathy. The main factors found to be associated with nephropathy are duration of diabetes, glycemic control, and the presence of retinopathy.…”

Molecular Mechanism of Pathogenesis and Management of Diabetic Nephropathy

“…It mainly affects macro and micro-blood vessels resulting atherosclerosis, cardiomyopathy, retinopathy, nephropathy and neuropathy etc. Primarily, the activation of PKC-β PKCα, PKC β-I, β-II, and epsilon mRNA have been reported in high proteinuria and cell damage [15]. PKC-ß induces the mesangial proliferative glomerulonephritis (L).…”

“…Proteinuria is useful for the screening and diagnosis of overt diabetic nephropathy [15,16]. It is an independent risk factor for decline in GFR in CKD and also for cardiovascular disease.…”

“…It is an independent risk factor for decline in GFR in CKD and also for cardiovascular disease. The persistent proteinuria induces local inflammation in the kidney, resulting damage to glomerular and tubule-interstitial damage, through release of prostaglandins [15]. Thus, antiinflammatory drugs like COX-2 inhibitors and those agents which inhibit proteinuria may be effective in preventing the progress of DN.…”