Identification of New Serum Markers for Detection of Abuse With Erythropoietin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01320449
First received: March 18, 2011
Last updated: July 31, 2012
Last verified: July 2012

March 18, 2011
July 31, 2012
August 2011
July 2012   (final data collection date for primary outcome measure)
Changes in serum protein isoforms measured by proteomics [ Time Frame: 10 months ] [ Designated as safety issue: No ]
We 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.
Same as current
Complete list of historical versions of study NCT01320449 on ClinicalTrials.gov Archive Site
Changes in substrate metabolism in relation to rHuEpo treatment and endurance training [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Metabolic 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.
Same as current
Not Provided
Not Provided
 
Identification of New Serum Markers for Detection of Abuse With Erythropoietin
Identification of New Serum Markers for Detection of Abuse With Erythropoietin

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Substance Abuse Problem
  • Drug: recombinant 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.
  • Behavioral: Training
    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.
  • Other: Placebo
    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.
  • Placebo Comparator: No training + placebo
    10 young men being investigated with 10 weeks apart. The will receive placebo injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.
    Intervention: Other: Placebo
  • Active Comparator: No training + EPO
    10 young men being investigated with 10 weeks apart. During the 10 weeks participants will receive EPO injections twice a week. Blood samples, blood pressures as well as VO2-mas tests will be obtained during the 10 weeks.
    Intervention: Drug: recombinant human erythropoietin
  • Active Comparator: Training + placebo
    10 young men will be trained for 10 weeks and investigated before and after. They will receive placebo injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.
    Interventions:
    • Behavioral: Training
    • Other: Placebo
  • Active Comparator: Training + EPO
    10 young men will be investigated with 10 weeks apart. During the ten weeks they will train 3 times a week and receive EPO injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.
    Interventions:
    • Drug: recombinant human erythropoietin
    • Behavioral: Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01320449
M-20110035
No
Birgitte Nellemann, University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Britt Christensen, M.Sc., PhD Aarhus University Hospital
University of Aarhus
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP