Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Study Overview
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Brief Summary
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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.

Official Title
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Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Conditions
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Substance Abuse Problem

Intervention / Treatment
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* Drug: recombinant human erythropoietin
* Behavioral: Training
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No training + placebo<br>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<br>* 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.<br>|
| Active Comparator: No training + EPO<br>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<br>* 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.<br>|
| Active Comparator: Training + placebo<br>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<br>* 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.<br>Other: Placebo<br>* 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.<br>|
| Active Comparator: Training + EPO<br>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<br>* 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.<br>Behavioral: Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPO, Proteomics, Carbohydrate metabolism, Fat metabolism, Protein metabolism