- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02685241
Monitoring of Biomarkers by Portable Breath Gas Sensors: an Exploratory Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Pneumology
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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General population
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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one hour, single measurement, no follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: one hour, single measurement, no follow-up
|
one hour, single measurement, no follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Malcolm Kohler, MD, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BASEC-Nr. PB-2016-00141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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