Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Substance Abuse Problem Clinical Trial

Official title:

Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320449
• Other study ID #: M-20110035
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: July 31, 2012
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Substance Abuse Problem
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Department of Endocrinology, Research Laboratories	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum protein isoforms measured by proteomics	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.	10 months	No
Secondary	Changes in substrate metabolism in relation to rHuEpo treatment and endurance training	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.	10 months	No