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

R

Radboud University Medical Center

Status and phase

Completed
Phase 1

Conditions

Hyperoxia
Hypoxia

Treatments

Other: Hyperoxia
Other: Hypoxia

Study type

Interventional

Funder types

Other

Identifiers

NCT01889823
OX1

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Hypoxia
Experimental group
Description:
Subjects will be breathing an individualized mix of nitrogen and room air titrated to an oxygen saturation of 80-85%.
Treatment:
Other: Hypoxia
Hyperoxia
Experimental group
Description:
Subjects will be breathing 100% of oxygen
Treatment:
Other: Hyperoxia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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