Exosome Proteomics to Detect EPO

Study Overview
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Brief Summary
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The role of exosomes in cell signalling has only recently been appreciated and is a hugely exciting and rapidly growing area, and combined with LC-MS/MS proteomics, can overcome traditional barriers to proteomics in doping applications. To our knowledge, no research has yet been undertaken to explore whether the highly promising combination of exosome proteomics has utility for rhEPO detection. The applications are extensive; the diagnostic value of differentially regulated proteins could be further validated against the existing IEF EPO WADA accredited tests using samples collected during this study, used to study altitude hypoxia versus exogenous EPO administration (WADA current targeted research 2017), investigated as a platform approach to ESA and HIF agents more generally, as well as facilitate development of direct ELISA high throughput tests.

Official Title
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Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes

Conditions
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Healthy

Intervention / Treatment
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* Drug: Erythropoietin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VO2max of at least 55+/-2 for men and 50+/-2 for women BMI between 18 and 27 Resting hematocrit of less than 46% Exclusion Criteria: Chronic disease deemed by the medical doctor to affect the outcome Competitive athlete subject to doping control Use of other prescription medicine deemed by the medical doctor to interact with the study drug Allergy or otherwise unacceptable side effects toward the study drug Smoker Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline infusion | Drug: Placebo<br>* Subjects receive weekly infusions of saline<br>|
| Experimental: EPO<br>Erythropoetin infusion (9 IU/kg) | Drug: Erythropoietin<br>* Subjects receive weekly infusions of EPO<br>|
| Experimental: EPO II<br>Erythropoetin infusion (20 IU/kg) | Drug: Erythropoietin<br>* Subjects receive weekly infusions of EPO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood proteome enrichment pathway analysis in GO annotation | Change in enrichment (measured in blood and assessed using GO annotation) | At baseline and after week 3 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood markers of iron | Change in blood markers of iron homeostasis | At baseline and after week 3 of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPO