Exosome Proteomics to Detect EPO

NCT ID: NCT03700515

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-10-15

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Saline infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects receive weekly infusions of saline

EPO

Erythropoetin infusion (9 IU/kg)

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type DRUG

Subjects receive weekly infusions of EPO

EPO II

Erythropoetin infusion (20 IU/kg)

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type DRUG

Subjects receive weekly infusions of EPO

Interventions

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Erythropoietin

Subjects receive weekly infusions of EPO

Intervention Type DRUG

Placebo

Subjects receive weekly infusions of saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tasmania

OTHER

Sponsor Role collaborator

Morten Hostrup, PhD

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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August Krogh Building

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Morten Hostrup, PhD

Role: primary

+4524474785

Other Identifiers

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EPO-EXO

Identifier Type: -

Identifier Source: org_study_id

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