Identification of New Serum Markers for Detection of Abuse With Erythropoietin

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01320449
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Arms: 4
• Duration (Months): 11
• Patients Per Site: 17.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Substance Abuse Problem	Drug: recombinant human erythropoietin; Behavioral: Training; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Identification of New Serum Markers for Detection of Abuse With Erythropoietin
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Changes in serum protein isoforms measured by proteomics [10 months]

   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

1. Changes in substrate metabolism in relation to rHuEpo treatment and endurance training [10 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Birgitte Nellemann, MD PhDstudent, University of Aarhus
• ClinicalTrials.gov Identifier: NCT01320449
• Other Study ID Numbers: M-20110035
• First Posted: Mar 22, 2011
• Last Update Posted: Aug 1, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Birgitte Nellemann, MD PhDstudent, University of Aarhus: EPO; Proteomics; Carbohydrate metabolism; Fat metabolism; Protein metabolism
• Additional relevant MeSH terms: Substance-Related Disorders; Epoetin Alfa

Study Results

No Results Posted as of Aug 1, 2012