Exosome Proteomics to Detect EPO

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Erythropoietin

• Registration Number: NCT03700515
• Lead Sponsor: Morten Hostrup, PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Status Verified: 2019-09
• Study Start: 2019-09-04
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline infusion
EPO	Erythropoietin	Erythropoetin infusion (9 IU/kg)
EPO II	Erythropoietin	Erythropoetin infusion (20 IU/kg)

Primary Outcome Measures

Name	Time	Method
Blood proteome enrichment pathway analysis in GO annotation	At baseline and after week 3 of treatment	Change in enrichment (measured in blood and assessed using GO annotation)

Secondary Outcome Measures

Name	Time	Method
Blood markers of iron	At baseline and after week 3 of treatment	Change in blood markers of iron homeostasis

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark