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Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01320449
Enrollment
35
Registered
2011-03-22
Start date
2011-08-31
Completion date
2012-07-31
Last updated
2012-08-01

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

Conditions

Substance Abuse Problem

Keywords

EPO, Proteomics, Carbohydrate metabolism, Fat metabolism, Protein metabolism

Brief summary

Epo increases red blood cell production and hence the amount of oxygen that can be transported around the body. It is shown that prolonged use of synthetic Epo (rHuEpo) leads to an increase in the period of time a given physical work can be performed, therefore it will continue to be abused by athletes, especially in endurance sports. The existing method for measuring the abuse of rHuEpo approved by the World Anti-Doping Agency (WADA) is based on differences in the sugar groups bound to rHuEpo and Epo produced in the body, respectively. Proteomics is a method by which one can look at all the proteins in blood at the same time. Even proteins that have changed very little can be distinguished. The main objective of this project is to investigate the effect of prolonged treatment with rHuEpo on changes in blood proteins in healthy young men.

Interventions

DRUGrecombinant human erythropoietin

rHuEpo (5000 IU)is administered using a small syringe under the skin every other day for the first 2 weeks, on 3 consecutive days during week 3, and once a week from week 4-10.

BEHAVIORALTraining

For ten weeks participants will receive supervised endurance training on a bike three times a week. Physical effect will be examined with VO2-max tests before during and after the training period.

OTHERPlacebo

placebo (saline) is administered using a small syringe under the skin every other day for the first 2 weeks, on 3 consecutive days during week 3, and once a week from week 4-12.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy men * age 18-35 * untrained * BMI: 20-25

Exclusion criteria

* smokers * chronic diseases * malignancy (former or present) * alcohol, drug or EPO abuse

Design outcomes

Primary

MeasureTime frameDescription
Changes in serum protein isoforms measured by proteomics10 monthsWe wish to identify proteins or isoforms hereof that change with rHuEpo treatment, in order to identify new biomarkers in the blood that can be used to detect rHuEpo abuse.

Secondary

MeasureTime frameDescription
Changes in substrate metabolism in relation to rHuEpo treatment and endurance training10 monthsMetabolic and mechanistic effects of 10 weeks of training and use of EPO on fat and skeletal muscle tissue as well as on a whole body level. A variety of different tracers and indirect calorimetry will be used.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026