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
  Purpose

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.


Condition Intervention
Substance Abuse Problem
Drug: recombinant human erythropoietin
Behavioral: Training
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320449

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Endocrinology, Research Laboratories
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Britt Christensen, M.Sc., PhD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Birgitte Nellemann, MD PhDstudent, University of Aarhus
ClinicalTrials.gov Identifier: NCT01320449     History of Changes
Other Study ID Numbers: M-20110035
Study First Received: March 18, 2011
Last Updated: July 31, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
EPO
Proteomics
Carbohydrate metabolism
Fat metabolism
Protein metabolism

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014