Exosome Proteomics to Detect EPO

Sponsor

Morten Hostrup, PhD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03700515

Collaborator

University of Tasmania (Other)

Enrollment

Location

Arms

13.4

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Erythropoietin Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes

Actual Study Start Date :

Sep 4, 2019

Anticipated Primary Completion Date :

Oct 15, 2020

Anticipated Study Completion Date :

Oct 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Saline infusion	Drug: Placebo Subjects receive weekly infusions of saline
Experimental: EPO Erythropoetin infusion (9 IU/kg)	Drug: Erythropoietin Subjects receive weekly infusions of EPO
Experimental: EPO II Erythropoetin infusion (20 IU/kg)	Drug: Erythropoietin Subjects receive weekly infusions of EPO

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Saline infusion

Drug: Placebo

Subjects receive weekly infusions of saline

Experimental: EPO

Erythropoetin infusion (9 IU/kg)

Drug: Erythropoietin

Subjects receive weekly infusions of EPO

Experimental: EPO II

Erythropoetin infusion (20 IU/kg)

Drug: Erythropoietin

Subjects receive weekly infusions of EPO

Outcome Measures

Primary Outcome Measures

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

Blood markers of iron [At baseline and after week 3 of treatment]
Change in blood markers of iron homeostasis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	August Krogh Building	Copenhagen		Denmark

Sponsors and Collaborators

Morten Hostrup, PhD
University of Tasmania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morten Hostrup, PhD, Associate Professor, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT03700515

Other Study ID Numbers:

EPO-EXO

First Posted:

Oct 9, 2018

Last Update Posted:

Sep 25, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Morten Hostrup, PhD, Associate Professor, University of Copenhagen

EPO

Additional relevant MeSH terms:

Epoetin Alfa

Study Results

No Results Posted as of Sep 25, 2019