DiabetesNCT03238547
Screening of Microalbuminuria Using a Semi-quantitative UACR Test
An observational study of Diabetes and Microalbuminuria, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Microalbuminuria
- What is being tested?
- semi-quantitative urine albumin-to-creatinine ratio test and standard quantitative spot urine albumin-to-creatinine ratio
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 31 Dec 2019
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetic patients following Seoul National University Hospital
Who may be able to join
- diabetes
Who cannot join
- microscopic hematuria
- pyuria
- urinary cast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes
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
- Being tested
- semi-quantitative urine albumin-to-creatinine ratio test, standard quantitative spot urine albumin-to-creatinine ratio
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-quantitative urine albumin-to-creatinine ratio testDiagnostic test
measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test
standard quantitative spot urine albumin-to-creatinine ratioDiagnostic test
measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay
| Study group | Role | What they receive |
|---|---|---|
| diabetes | Diabetes patients with normal renal function and normal urinalysis Receives: Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test; Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity and Specificity
Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Ki Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238547
- Sponsor's protocol ID
- URiSCAN_SNU_01
- Status last verified
- Jan 2020
- First submitted
- 29 Jul 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03238547
- Acronym / sponsor ID
- URiSCAN_SNU_01
- Conditions
- Diabetes, Microalbuminuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetes | – | Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test, Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratioDiabetes patients with normal renal function and normal urinalysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients following Seoul National University Hospital
Key inclusion criteria (1 listed)
- diabetes
Key exclusion criteria (3 listed)
- microscopic hematuria
- pyuria
- urinary cast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-quantitative urine albumin-to-creatinine ratio testmeasurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test | Diagnostic test | diabetes |
| standard quantitative spot urine albumin-to-creatinine ratiomeasurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay | Diagnostic test | diabetes |
Primary outcome
Diagnostic Sensitivity and Specificity
Time frame: through study completion, an average of 18 months
Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Microalbuminuria, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity and Specificity (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.