Energy MetabolismNCT03121885
Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions
A study testing 30-minute movement activity and Hypoxia in people with Energy Metabolism and Hypoxia, run by Benjamin Gollasch at 1 site in Germany.
Trial summary
The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism, Hypoxia, Metabolism and Nutrition Disorder
- What is being tested?
- 30-minute movement activity and Hypoxia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- approval and written, informed consent
- healthy adults of varying fitness levels (age >18 years to 75 years)
Who cannot join
- chronic illness requiring any medication
- pregnancy
- limitations regarding functioning in the hypoxic chamber
- inability to follow simple instructions
- relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Experimental & Clinical Research Center
Berlin, 13125
About this study
Official title: MetaboDyn- Liquid-liquid Extraction of Single Drops of Whole Capillary Blood as a Reliable Method of Measuring Metabolic Effects of Exercise: A Pilot Study.
The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry.
- Being tested
- 30-minute movement activity, Hypoxia
- Medical subject headings
- Hypoxia, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-minute movement activityBehavioural
The subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill.
HypoxiaOther
The 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode.
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS.
A drop of capillary blood (20 µl) will be collected from the hyperemic earlobe for metabolomic analysis at the times t = 0 min (before starting), 10 min, 20 min and 30 min during the activity, and t = 50 and 60 min taken in the recovery phase. The oxygen saturation and heart rate will be determined at the same time points by pulse oximetry and heart rate monitoring, as well as blood gas analyses and subjective self-perception of energy availability on a quantitative scale throughout exercise.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Jan 2017
- Primary completion20 Jul 2017
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin Gollasch
- Sponsor type
- University, hospital or other
- Collaborators
- Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin
- Responsible party
- Sponsor-investigator, Benjamin Gollasch, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121885
- Sponsor's protocol ID
- MetaboDyn
- Status last verified
- Jul 2017
- First submitted
- 31 Mar 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Liquid-liquid extraction of single drops of whole capillary blood with collaborator partner MDC
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MetaboDyn- Liquid-liquid Extraction of Single Drops of Whole Capillary Blood as a Reliable Method of Measuring Metabolic Effects of Exercise: A Pilot Study.
- ClinicalTrials.gov ID
- NCT03121885
- Acronym / sponsor ID
- MetaboDyn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Benjamin GollaschUniversity, hospital or other
- Collaborators
- Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- approval and written, informed consent
- healthy adults of varying fitness levels (age >18 years to 75 years)
Key exclusion criteria (5 listed)
- chronic illness requiring any medication
- pregnancy
- limitations regarding functioning in the hypoxic chamber
- inability to follow simple instructions
- relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30-minute movement activityThe subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill. | Behavioural | – |
| HypoxiaThe 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode. | Other | – |
Primary outcome
Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS.
Time frame: 6 months
A drop of capillary blood (20 µl) will be collected from the hyperemic earlobe for metabolomic analysis at the times t = 0 min (before starting), 10 min, 20 min and 30 min during the activity, and t = 50 and 60 min taken in the recovery phase. The oxygen saturation and heart rate will be determined at the same time points by pulse oximetry and heart rate monitoring, as well as blood gas analyses and subjective self-perception of energy availability on a quantitative scale throughout exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: Yes. Liquid-liquid extraction of single drops of whole capillary blood with collaborator partner MDC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-minute movement activity and Hypoxia in people with Energy Metabolism and Hypoxia, run by Benjamin Gollasch at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.