Screening of Microalbuminuria Using a Semi-quantitative UACR Test

NCT03238547 | Completed FDA Device

• 1 other identifier: URiSCAN_SNU_01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Microalbuminuria

Outcome Measures

Primary Outcomes (1)

• Diagnostic Sensitivity and Specificity

  Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method

  through study completion, an average of 18 months

Study Arms (1)

diabetes

Diabetes patients with normal renal function and normal urinalysis

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

Interventions

semi-quantitative urine albumin-to-creatinine ratio test DIAGNOSTIC_TEST

measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test

diabetes

standard quantitative spot urine albumin-to-creatinine ratio DIAGNOSTIC_TEST

measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay

diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

diabetic patients following Seoul National University Hospital

You may qualify if:

• diabetes

You may not qualify if:

• microscopic hematuria
• pyuria
• urinary cast

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 3, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)