Exosome Proteomics to Detect EPO

September 24, 2019 updated by: Morten Hostrup, PhD

Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • August Krogh Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood proteome enrichment pathway analysis in GO annotation
Time Frame: At baseline and after week 3 of treatment
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
Time Frame: At baseline and after week 3 of treatment
Change in blood markers of iron homeostasis
At baseline and after week 3 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morten Hostrup, PhD

Collaborators

University of Tasmania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 4, 2019

Primary Completion (ANTICIPATED)

October 15, 2020

Study Completion (ANTICIPATED)

October 15, 2020

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPO-EXO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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