The Biosensor Using the Target Urine VOCs for Detecting DKD Diabetic Kidney Disease

NCT ID: NCT07137351

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2025-05-13

Brief Summary

Volatile organic compounds (VOCs) are easily evaporated substances produced by pathophysiologic metabolism and have been utilized in research as potential new biomarkers for differentiating various diseases, acting as the odor imprints of each disease.

Researchers used metal oxide semiconductors to examine the properties of VOCs produced by diabetic kidney disease patients. Also, the VOCs of those with diabetic kidney disease were then compared with those of healthy individuals and patients with nephrotic syndrome.

The study found that VOCs primarily composed of hydrogen, methanol, and sulfate in diabetic kidney disease patients had a significantly different ability to release free electrons from the metal oxide semiconductors compared to healthy individuals and patients with nephrotic syndrome from other causes. This finding suggested that VOCs could be used as biomarkers which could lead to the replacement of renal biopsy for diagnosis in the future.

Detailed Description

This study was a descriptive cohort study. General data such as age, gender, medications, other medical conditions, or chronic diseases that might have affected the urine VOCs test were reviewed and recorded from the medical records of subjects who attended the outpatient clinic of the Internal Medicine department at the Suranaree University of Technology Hospital from March 2024 to July 2024. Urine samples from diabetic patients, both with and without abnormal proteinuria, were compared with normal urine samples and urine samples from patients with NS from other causes.

Conditions

Urine VOCs From DKD and Nephrotic Syndrome Pateints

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

3

็Healthy volunteer, DKD pateints, other causes of Nephrotic syndrome

The Biosensor Using the Target Urine Volatile Organic Compounds

Intervention Type: DIAGNOSTIC_TEST

The authors opted to utilize five distinct commercially available semiconductors (metal oxide sensors) to detect all the targeted VOCs which were manufactured by Figaro company.

Urine samples from patients were placed in a urine container, which was then placed into the VOCs detection device. The lid was closed, and the system was set to operate in a closed-loop mode at a room temperature of 25 degrees Celsius. The device then vacuumed VOCs from the urine samples of the patients through a gas tube into the biosensor chamber located on top, where analysis was performed.

็Healthy volunteer

็Healthy volunteer = normal subject or diabetes pateint without proteinuria (\< 300 mg/day)

The Biosensor Using the Target Urine Volatile Organic Compounds

Intervention Type: DIAGNOSTIC_TEST

The authors opted to utilize five distinct commercially available semiconductors (metal oxide sensors) to detect all the targeted VOCs which were manufactured by Figaro company.

Urine samples from patients were placed in a urine container, which was then placed into the VOCs detection device. The lid was closed, and the system was set to operate in a closed-loop mode at a room temperature of 25 degrees Celsius. The device then vacuumed VOCs from the urine samples of the patients through a gas tube into the biosensor chamber located on top, where analysis was performed.

DKD pateints

DKD = diabetic kidney disease with proteinuria (\> 1 g/day) with confirmed by pathological results

The Biosensor Using the Target Urine Volatile Organic Compounds

Intervention Type: DIAGNOSTIC_TEST

The authors opted to utilize five distinct commercially available semiconductors (metal oxide sensors) to detect all the targeted VOCs which were manufactured by Figaro company.

Urine samples from patients were placed in a urine container, which was then placed into the VOCs detection device. The lid was closed, and the system was set to operate in a closed-loop mode at a room temperature of 25 degrees Celsius. The device then vacuumed VOCs from the urine samples of the patients through a gas tube into the biosensor chamber located on top, where analysis was performed.

other causes of Nephrotic syndome

NS = other casues of nephrotic syndrome, pateints must have with proteinuria \> 3.5 g/day) with confirmed by pathological results. In addition, They must have no DM in the illness profile.

The Biosensor Using the Target Urine Volatile Organic Compounds

Intervention Type: DIAGNOSTIC_TEST

The authors opted to utilize five distinct commercially available semiconductors (metal oxide sensors) to detect all the targeted VOCs which were manufactured by Figaro company.

Urine samples from patients were placed in a urine container, which was then placed into the VOCs detection device. The lid was closed, and the system was set to operate in a closed-loop mode at a room temperature of 25 degrees Celsius. The device then vacuumed VOCs from the urine samples of the patients through a gas tube into the biosensor chamber located on top, where analysis was performed.

Interventions

The Biosensor Using the Target Urine Volatile Organic Compounds

The authors opted to utilize five distinct commercially available semiconductors (metal oxide sensors) to detect all the targeted VOCs which were manufactured by Figaro company.

Urine samples from patients were placed in a urine container, which was then placed into the VOCs detection device. The lid was closed, and the system was set to operate in a closed-loop mode at a room temperature of 25 degrees Celsius. The device then vacuumed VOCs from the urine samples of the patients through a gas tube into the biosensor chamber located on top, where analysis was performed.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Metal oxide semiconductor detecting VOCs

Eligibility Criteria

Inclusion Criteria

• Age > 20 years
• In DKD and NS groups must undergone renal biopsy before study

Exclusion Criteria

• Patients with an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2
• Pregnancy
• Ambiguous pathological results

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suranaree University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Chatchai Kreepala, MD

Associate Professor Dr. Chatchai Kreepala, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Medicine, Suranaree University of Technology

Nakhon Ratchasima, , Thailand

Countries

Thailand

Other Identifiers

EC-67-0001

Identifier Type: -

Identifier Source: org_study_id