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Clinical Trials/NCT02685241
NCT02685241
Completed
Not Applicable

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

University of Zurich1 site in 1 country70 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Population
Sponsor
University of Zurich
Enrollment
70
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
October 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Malcolm Kohler

Prof. Dr. med.

University of Zurich

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: one hour, single measurement, no follow-up

Secondary Outcomes

  • 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)

Study Sites (1)

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