Identification of New Serum Markers for Detection of Abuse With Erythropoietin

University of Aarhus

Status: Completed

Conditions: Substance Abuse Problem

Treatments: Other: Placebo; Behavioral: Training; Drug: recombinant human erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT01320449

M-20110035

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 4 patient groups, including a placebo group

No training + placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

No training + EPO

Active Comparator group

Description:

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.

Treatment:

Drug: recombinant human erythropoietin

Training + placebo

Active Comparator group

Description:

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.

Treatment:

Other: Placebo

Behavioral: Training

Training + EPO

Active Comparator group

Description:

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.

Treatment:

Drug: recombinant human erythropoietin

Behavioral: Training