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

General Population Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685241
• Other study ID #: BASEC-Nr. PB-2016-00141
• Status: Completed
• Start date: June 2016
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Age = 18 years

Exclusion Criteria:

• Moribund or severe disease prohibiting protocol adherence

• Physical or intellectual impairment precluding informed consent or protocol adherence

• Pregnant patients

Related Conditions & MeSH terms

• General Population

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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