Exosome Proteomics to Detect EPO

Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03700515

Enrollment

Registered

2018-10-09

Start date

2019-09-04

Completion date

2020-10-15

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

EPO

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.

Interventions

DRUGErythropoietin

Subjects receive weekly infusions of EPO

DRUGPlacebo

Subjects receive weekly infusions of saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Blood markers of iron	At baseline and after week 3 of treatment	Change in blood markers of iron homeostasis

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026