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HypoxiaPhase 1NCT01889823

Effects of Oxygen Status on Hypoxia Inducible Factor 1-α and Inflammation. A Pilot Proof of Principle Study.

A Phase 1 study testing Hypoxia and Hyperoxia in people with Hypoxia and Hyperoxia, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could be the result of activation of Hypoxia Inducible Factor, a transcription factor that is known to activate many cell systems aimed at cell… Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hypoxia, Hyperoxia
What is being tested?
Hypoxia and Hyperoxia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNetherlands
Study dates
Jun 2013to Dec 2014
Phase
Phase 1
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 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age ≥18 and ≤35 yrs
  • Male
  • Healthy

Who cannot join

  • Use of any medication
  • Smoking
  • History, signs or symptoms of cardiovascular disease
  • 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
Show all 21Show fewer
  • Hypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg)
  • Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)
  • Renal impairment (defined as plasma creatinine >120 μmol/l)
  • Liver enzyme abnormalities alkaline phosphatase>230 U/L and/or ALT>90 U/L
  • Medical history of any obvious disease associated with immune deficiency
  • CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
  • Participation in a drug trial or donation of blood 3 months prior to the experiment
  • Pre-existent lung disease or asthma
  • Use of recreational drugs within 21 days prior to experiment day
  • Visit to altitude >1500m within 4 weeks prior to the experiment
  • Air travel with flight time over 3 hours within 4 weeks prior to the experiment
  • History of acute mountain sickness
  • Recent hospital admission or surgery with general anaesthesia (<3 months)
  • Claustrophobia
  • Feelings of discomfort during a 10 minute test wearing the transparent respiratory helmet at the screening visit

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Intensive Care Medicine, Radboud University Nijmegen Medical Centre

    Nijmegen, Nijmegen, Gelderland, 6500 HB

Other trials in Netherlands

About this study

It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could be the result of activation of Hypoxia Inducible Factor, a transcription factor that is known to activate many cell systems aimed at cell survival, including the inflammatory response. The anti-inflammatory effects of hyperoxia could be the annihilation of Hypoxia Inducible Factor, but also a decrease in inflammation due to oxygen toxicity resulting in a decrease in clearance of pathogens. These effects have been sparsely studied in humans. Therefore, we hypothesize that hypoxia results in an increase in Hypoxia Inducible Factor in circulating leukocytes and increases inflammatory reactions, whereas hyperoxia decreases these reactions.

Conditions
Hypoxia, Hyperoxia
Being tested
Hypoxia, Hyperoxia
Keywords
Oxygen, Hypoxia, Hyperoxia, Inflammation, Innate immunity
Medical subject headings
Hypoxia, Hyperoxia, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypoxiaOther

    Subjects will be breathing an individualized mix of nitrogen and room air titrated to an oxygen saturation of 80-85%.

  • HyperoxiaOther

    Subjects will be breathing 100% oxygen

Study groups in NCT01889823
Study groupRoleWhat they receive
HypoxiaExperimentalSubjects will be breathing an individualized mix of nitrogen and room air titrated to an oxygen saturation of 80-85%.
Receives: Other: Hypoxia
HyperoxiaExperimentalSubjects will be breathing 100% of oxygen
Receives: Other: Hyperoxia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypoxia Inducible Factor 1 alpha in circulating leukocytes

    Hypoxia Inducible Factor 1 alpha in circulating neutrophils, lymphocytes and monocytes as measured with flow cytometry

    Measured: 24 hours

Secondary outcomes (24)

  1. Hypoxia Inducible Factor mRNA and anti Hypoxia Inducible Factor mRNA in circulating leukocytes

    Measured: 24 hours

  2. Reactive Oxygen Species in circulating leukocytes

    ROS in circulating leukocytes, subclassified in neutrophils and monocytes

    Measured: 24 hours

  3. Phagocytic function of circulating leukocytes

    Measured: 24 hours

  4. cytokine production after ex vivo stimulation of leukocytes

    Measured: 24 hours

  5. circulating cytokines (including but not limited to IL-6, IL-10, IL-1RA)

    Measured: 24 hours

  6. Hemodynamic parameters

    Blood pressure, heart frequency, cardiac output measurement

    Measured: 24 hours

  7. ventilatory response

    Measures of ventilation: respiratory rate, blood gas changes

    Measured: 24 hours

  8. adenosine metabolism

    urine and plasma adenosine,adenosine receptor mRNA, purines

    Measured: 24 hours

  9. alkaline phosphatase

    Measured: 24 hours

  10. cognitive function

    neuropsychologic assessment of cognitive function

    Measured: 24 hours

  11. Hepcidin and iron parameters

    Measured: 24 hours

  12. catecholamines

    adrenaline, noradrenaline and dopamine

    Measured: 24 hours

  13. Neutrophil function

    Measured: 24 hours

  14. body temperature

    Measured: 24 hours

  15. oxygen saturation and PaO2

    Measured: 24 hours

  16. subjective symptoms

    Measured: 24 hours

  17. high sensitive troponin

    Measured: 24 hours

  18. iFABP

    Measured: 24 hours

  19. Brain specific proteins

    Measured: 24 hours

  20. endocan

    Measured: 24 hours

  21. adrenomedullin

    Measured: 24 hours

  22. EPO

    Measured: 24 hours

  23. VEGF

    Measured: 24 hours

  24. Heart rate variability

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionAug 2013
  4. Study completionDec 2014

Resources

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889823
Sponsor's protocol ID
OX1
Status last verified
Mar 2015
First submitted
26 Jun 2013
Last updated
25 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hypoxia and Hyperoxia in people with Hypoxia and Hyperoxia, run by Radboud University Medical Center at 1 site in Netherlands.

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 3 inclusion and 21 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 25 Mar 2015. 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 Netherlands. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Hypoxia Inducible Factor 1 alpha in circulating leukocytes (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01889823.

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 25 Mar 2015.

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