Monitoring of Biomarkers by Portable Breath Gas Sensors: an Exploratory Study

Completed

• Conditions: General Population

• Registration Number: NCT02685241
• Lead Sponsor: University of Zurich

Brief Summary

Breath analysis is a non-invasive procedure to detect and monitor diseases and it is particularly attractive for patients who have to routinely check biomarkers, such as diabetics (blood glucose) or end-stage renal disease patients (creatinine). Preliminary data in a small study with healthy subjects showed a high correlation between blood glucose levels and acetone. Therefore, the objective of this study is to correlate biomarkers (glucose level and creatinine, respectively) with the corresponding target breath components (acetone and NH3, respectively) detected by portable gas sensors in the general population and to assess possible predictive models for biomarker estimations from the corresponding target breath component and predictive models to estimate abnormal biomarker concentrations.

Detailed Description

Breath analysis is a non-invasive procedure to detect and monitor diseases and it is particularly attractive for patients who have to routinely check biomarkers, such as diabetics (blood glucose) or end-stage renal disease patients (creatinine). The proposed breath sensors analyse breath in real-time with on-line display of breath parameters, are portable, simple to operate, inexpensive and offer a sufficiently low limit of detection for the target breath markers, thus making them of high interest for daily clinical practice. Preliminary data in a small study with healthy subjects showed a high correlation between blood glucose levels and acetone.

The primary objective of this study is to correlate biomarkers (glucose level and creatinine, respectively) with the corresponding target breath components (acetone and NH3, respectively) detected by portable gas sensors in the general population. The secondary objectives of the study are to assess possible predictive models for biomarker estimations from the corresponding target breath component and predictive models to estimate abnormal biomarker concentrations.

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Study Start: 2016-06
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Informed consent
• Age ≥ 18 years

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Exclusion Criteria

• Moribund or severe disease prohibiting protocol adherence
• Physical or intellectual impairment precluding informed consent or protocol adherence
• Pregnant patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the correlation between biomarkers (glucose levels and creatinine, respectively) and target breath components (acetone and NH3, respectively) detected by portable gas sensors	one hour, single measurement, no follow-up

Secondary Outcome Measures

Name	Time	Method
The assessment of possible predictive models for biomarker estimations (glucose levels and creatinine) from the corresponding target breath component (acetone and NH3) and predictive models to estimate the abnormal biomarker concentrations.	one hour, single measurement, no follow-up

Trial Locations

Locations (1)

University Hospital Zurich, Division of Pneumology; 🇨🇭 Zurich, ZH, Switzerland