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

NCT07137351 | Withdrawn

• 1 other identifier: EC-67-0001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urine VOCs From DKD and Nephrotic Syndrome Pateints

Keywords

VOCs; Biosensor; diabetic kidney disease; nephrotic syndrome

Outcome Measures

Primary Outcomes (1)

• Characteristic of VOCs in DKD

  Electrical resistance characteristic VOCs by semiconductors in DKD when compared to normal and NS

  March 2024- July 2024

Study Arms (4)

3

็Healthy volunteer, DKD pateints, other causes of Nephrotic syndrome

Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds

็Healthy volunteer

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

Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds

DKD pateints

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

Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds

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.

Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds

Interventions

The Biosensor Using the Target Urine Volatile Organic Compounds 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.

Also known as: Metal oxide semiconductor detecting VOCs

3; DKD pateints; other causes of Nephrotic syndome; ็Healthy volunteer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suranaree University of Technology: lead

Study Sites (1)

Institute of Medicine, Suranaree University of Technology

Nakhon Ratchasima, 30000, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Diabetic Nephropathies; Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Nephrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr. Chatchai Kreepala, M.D.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: August 22, 2025
• Study Start: May 12, 2025
• Primary Completion: May 12, 2025
• Study Completion: May 13, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)