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A pilot study on the association of the ergospirometric evaluation of gas metabolism and cellular oxygen metabolism measured by the Cellular Oxygen METabolism Monitor (COMET)

A pilot study on the association of the ergospirometric evaluation of gas metabolism and cellular oxygen metabolism measured by the Cellular Oxygen METabolism Monitor (COMET) - SPICOMET

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016670
Enrollment
15
Registered
2019-02-21
Start date
2019-02-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

Group 1: T0: written and informed consent application Electrocardiography preparation spiroergometry T1 [Baseline]: dynamic COMET measurement respiratory gas analysis without exercise measurement of

Sponsors

NWG Translational Septomics, Zentrum für Innovationskompetenz (ZIK) Septomics, Universitätklinikum Jena
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - written and informed consent - suitability for exercise test (Physical Activity Readiness Questionnaire)

Exclusion criteria

Exclusion criteria: - significant pre-existing cardiological or pulmonal disease as well as significant diseases of the musculoskeletal system -absolute contraindication for 5-aminolevulinic-acid-patch (required for COMET measurement: allergy to 5-aminolevulinic-acid-hydrocholride, acrylic adhesives, pigmented polyethylene or aluminized polyester, porphyria, skin disease which are caused or aggravated by sun light, increased sensitivity to sun light) - allergy to Nonivamid or Nicoboxil (ingredients Finalgon®) - pregnancy/breastfeeding - participation in another intervention study - previous participation in this study

Design outcomes

Primary

MeasureTime frame
The primary aim is the evaluation of the association between mitochondrial oxygen consumption (mitoVO2) and the spiroergometrically measured oxygen uptake (VO2) over the time points T1 – T4.

Secondary

MeasureTime frame
- Evaluation of the association between mitochondrial oxygen tension (mitoPO2) and the spiroergometrically measured oxygen uptake (VO2) over the time points T1 – T4. - Evaluation of the association between mitochondrial oxygen delivery (mitoDO2) and the spiroergometrically measured oxygen uptake (VO2) over the time points T1 – T4. - Corresponding analyses for mitoPO2, mitoVO2 and mitoDO2 and other variables from spiroergometry. - Corresponding analyses for mitoPO2, mitoVO2 and mitoDO2 and variables from blood gas analysis. - Characterisation of the course of mitoPO2, mitoVO2 and mitoDO2 between T1 – T4. Additional research questions: - Exploratory analysis on the influence of the maximum oxygen intake (VO2:max) on baseline values (T1) of mitoPO2, mitoVO2 and mitoDO2 - Activity induced differences in mitoPO2, mitoVO2 and mitoDO2 between T1 and the last load level during spiroergometry

Countries

Germany

Contacts

Public ContactPhilipp Baumbach

NWG Translational Septomics, Zentrum für Innovationskompetenz (ZKS) Septomics, Universitätsklinikum Jena

Philipp.Baumbach@med.uni-jena.de+49-3641-9-325-798

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026