The primary objective of this study is to observe the association between age and mitoPO2 values. The secondary objective is to evaluate whether there is also an association between age and the mitoVO2 values. Further objectives are to investigate…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Veroudering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MitoPO2 (mmHg). Ten mitoPO2 (mmHg) baseline measurements will be performed on
both the sternum and upper arm of all subjects. The mean and standard deviation
of those measurements will compute the baseline mitoPO2 for every participant.
Secondary outcome
MitoVO2 (mmHg/second). Applying pressure on the probe will cause a temporary
halt of circulation to the mitochondria. As the oxygen consumption continues,
this will result in a time-dependent decrease in mitoPO2 from which the mitoVO2
can be calculated in mmHg/second. Three mitoVO2 measurements will be performed
on both the sternum and the upper arm and the mean will be calculated for both.
Background summary
A new technique to measure mitochondrial oxygen tension was recently developed
and calibrated by our lab. With this technique, mitochondrial oxygen tension
*mitoPO2* and mitochondrial oxygen consumption *mitoVO2* can be measured in
human skin. This led to the introduction of the COMET, an acronym of Cellular
Oxygen METabolism (COMET, Photonics Healthcare B.V. Utrecht) which enables
bed-side monitoring of mitoPO2 and mitoVO2 in real-time. Previous studies have
illustrated the potential of these measurements in various clinical conditions,
unfortunately the influence of aging and chronic disease has not been
examined. Before the COMET monitor can be used in clinical settings, it has to
be known if these factors have any influence on the measurements. This study
will therefore, examine the association between age and mitoPO2 and mitoVO2
values. Secondly, it will investigate whether there is any association between
comorbidity and mitoPO2.mitoVO2. Lastly, the study will evaluate if mitoPO2 and
mitoVO2 values differ between measurement location namely, the upper arm or
sternum. This is because measurement locations vary in different clinical
settings.
Study objective
The primary objective of this study is to observe the association between age
and mitoPO2 values. The secondary objective is to evaluate whether there is
also an association between age and the mitoVO2 values. Further objectives are
to investigate the association between diabetes, obesity and neurodegenerative
diseases and mitoPO2 and mitoVO2 values. Lastly, the study will evaluate
whether mitoPO2 and mitoVO2 values differ between measurements done on the
upper arm or the sternum.
Study design
Single center observational trial in healthy volunteers and patients with
diabetes, obesity or neurodegenerative disease.
Study burden and risks
The intracellular oxygen measurements is a non-invasive measurement technique.
The specific discomfort for the subject is the aminolevulinic acid
containing-plaster that makes the skin sensitive for light. This plaster is
applied on the skin at least five hours before measurement. The participants
will not benefit directly from participation of the study. It will cost the
patients about an hour of extra time. Overall the risks are considered
negligible and the burden low. The study will aid in the development of new
techniques to improve therapy strategies for various diseases. Therefore the
group related benefits outweigh the risks in this study.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Aged between 18 years of age and 90 years of age
- Acceptable proficiency of the Dutch language
- Healthy volunteers without physical or mental illness
Comorbidity group
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Aged between 18 years of age and 90 years of age
- Acceptable proficiency of the Dutch language
- One of the underlying illnesses: neurodegenerative disease, diabetes mellitus
type II or obesity (BMI>30), no other relevant comorbidity
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Porphyria
- Known intolerance to components of the ALA plaster
- Presence of mitochondrial disease
- Pregnancy/lactation
- Patients with skin lesions on the measurement location which impede
measurements
- Incapability to provide inform consent, due to a mental condition interfering
with the ability to understand the provided information
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76685.078.21 |