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

NCT ID: NCT02685241

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-10-31

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.

Conditions

General Population

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

General population

General population

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Malcolm Kohler

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malcolm Kohler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

BASEC-Nr. PB-2016-00141

Identifier Type: -

Identifier Source: org_study_id