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Screening of Microalbuminuria Using a Semi-quantitative UACR Test

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Seoul National University

Status

Completed

Conditions

Diabetes
Microalbuminuria

Treatments

Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test
Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio

Study type

Observational

Funder types

Other

Identifiers

NCT03238547
URiSCAN_SNU_01

Details and patient eligibility

About

Microalbuminuria is an important biomarker for the development of diabetic nephropathy and cardiovascular complications. Since microalbuminuria is not easily detected on routine urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio (uACR) annually in a patient with diabetes mellitus. While the standard method is quantitative measurement using turbidimetric immunoassay, it requires high cost and special laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and inexpensive, could be used as a substitute to the current standard quantitative measurement. The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in patients with diabetes.

Enrollment

1,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diabetes

Exclusion criteria

  • microscopic hematuria
  • pyuria
  • urinary cast

Trial design

1,000 participants in 1 patient group

diabetes
Description:
Diabetes patients with normal renal function and normal urinalysis
Treatment:
Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio
Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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