Exosome Proteomics to Detect EPO

Healthy Clinical Trial

Official title:

Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700515
• Other study ID #: EPO-EXO
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Erythropoietin
Subjects receive weekly infusions of EPO
• Placebo
Subjects receive weekly infusions of saline

Locations

Country	Name	City	State
Denmark	August Krogh Building	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Morten Hostrup, PhD	University of Tasmania

Country where clinical trial is conducted

Denmark, 

Outcome

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