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Protocol of an observational study to evaluate diabetic nephropathy through detection of microalbuminuria in Indian
Gokulnath1, Manisha Sahay, Sanjay Kalra
1Department of Nephrology, St. Johns Medical College Hospital, Bangalore, India.
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.
Insights
Persistent microalbuminuria (MAU) screening in Indian type 2 diabetes patients using dipstick tests is a reliable method for early diabetic nephropathy detection. This approach can improve healthcare-seeking behaviors and inform treatment strategies.
Area of Science:
- Nephrology
- Endocrinology
- Public Health
Background:
- Type 2 diabetes mellitus (T2DM) is a growing concern in India.
- Diabetic nephropathy (DN) is a major complication of T2DM, leading to significant morbidity and mortality.
- Early detection of DN is crucial for effective management and prevention of kidney disease progression.
Purpose of the Study:
- To determine the prevalence of persistent microalbuminuria (MAU) in adult Indian patients with T2DM.
- To evaluate the clinical correlates of MAU detected by dipstick.
- To assess the predictive value of MAU for kidney disease and its role in prompting healthcare-seeking behavior.
Main Methods:
- A multicentric, cross-sectional study involving approximately 400,000 patients with T2DM.
- Screening for MAU using urine dipstick tests on random urine specimens over three visits within 180 days.
- Correlation of MAU with random blood glucose, height, weight, waist circumference, and blood pressure.
Main Results:
- The study aims to establish the prevalence of MAU in this population.
- Clinical correlates and predictive value for kidney disease will be analyzed.
- The utility of MAU as a cue for healthcare-seeking behavior will be investigated.
Conclusions:
- Dipstick detection of MAU is a rapid and reliable method for early identification of diabetic nephropathy.
- Early detection facilitates timely treatment planning and potentially improves patient outcomes.
- MAU screening can highlight disease burden and encourage proactive healthcare engagement.
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