Sea level: Sea level exposure / sea level exposure combined with microdoses of rHuEPO
Altitude: Altitude exposure / altitude exposure Iron metabolism
Study summary
The project represents a well powered study of the human response to altitude exposure combined with rHuEPO treatment. A total of 20 male and 20 female non-competing athletes will participate. The participants will be exposed to a period of hypobaric hypoxia at 2.320 m for four weeks and a sea-level intervention period of four weeks. The participants will be blinded and randomly allocated to intra venous injection with 20 IU per kg body weight of recombinant human erythropoietin or placebo every second day for the initial three weeks of each intervention. Included subjects will be runners due to the good possibility of recruitment and conduction of training at altitude. Samples are collected weekly for four weeks prior to each intervention period, during the four week intervention and four weeks after. This approach yields a highly valuable biobank for identification of markers sensitive to initiation of rHuEPO injections as well as termination of injections.
Eligibility
Sex
ALL
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Male: VO2max \> 48 ml/min/kg bodyweight and 5km run \< 22 min, Female: VO2max \> 43ml/min/kg bodyweight and 5km run \< 25 min A minimum of 2 years injury running training
Exclusion Criteria:
* Age, insufficient fitness or injury
Primary outcome measure(s)
Identification of metabolites in urine for rHuEPO and altitude exposure — 5 years Urine is analyzed by metabolomics and the metabolites for rHuEPO and altitude are verified using an exploratory design.
More specifically, the aim is to identify the resulting metabolites from altitude exposure and treatment with rHuEPO as these are not yet known In this WADA-supported research project, the aim is to identify high sensitivity biomarkers for altitude exposure through a metabolomics methods, as 'omics' methods have previously shown promising results in other exposure contexts. However, being the first of its kind in antidoping the resulting metabolites from rHuEPO misuse and altitude have not yet been identified. Thus, an exact description of these is not possible
Identification of human metabolites in serum for rHuEPO and altitude exposure — 5 years Human serum is analyzed by metabolomics and the metabolites for rHuEPO and altitude are verified using an exploratory design.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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