Showing stability of mitoPO2 and ODR in healthy volunteers during 4 time points in a day
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Mitochondriale oxygenatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
mitochondrial oxygen concentration (mitoPO2) en oxygen disappearance rate (ODR)
Secondary outcome
Heart rate
Non invasive bloedpressure
respiratory rate
Temperature
Sickness score
Background summary
Measuring mitochondrial oxygen tension is possible with a novel technique
developed by our lab. Demonstrating the stability of measurement of
mitochondrial oxygen tension (mitoPO2) and oxygen disappearance rate (ODR) in
healthy volunteers is a necessary step in the development of a new clinical
monitor for mitochondrial function.
In previous research we found a detoriaton of mitoPO2 and ODR in an endotoxemia
model in healthy volunteers. Showing stability of the measurements of mitoPO2
and ODR in a time control group will help interpreting the data. Furthermore
showing stability of mitoPO2 and ODR over time will help with further research.
Study objective
Showing stability of mitoPO2 and ODR in healthy volunteers during 4 time points
in a day
Study design
Single centre study with healthy volunteers in the Erasmus Medical Centre
Intervention
ALA plaster Pp-IX accumulation in the skin. This enables the mitochondrial
oxygen tension measurement.
Study burden and risks
The intracellular oxygen measurement is a non-invasive measurement technique.
The specific discomfort for the subject is that an aminolevulic acid
containing-plaster is applied that makes the skin sensitive for light. This
plaster is applied on the skin 5-8 hours before the measurement. The
measurement device is called the COMET monitor, able to measure cutaneous
mitoPO2 and ODR by means of oxygen-dependent quenching of delayed fluorescence
of mitochondrial protoporphyrin IX.
Overall, the study comes with a negligible risk and the burden is low.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
* 18-35 years of age
Exclusion criteria
* Mentally disabled
* Presence of mitochondrial disease
* Porphyria
* History of atrial or ventricular arrhythmia
* (Family) history of myocardial infarction or stroke under the age of 65 years
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
* Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
* Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
* History of renal impairment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65767.078.18 |