Identification of New Serum Markers for Detection of Abuse With Erythropoietin
NCT ID: NCT01320449
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2011-08-31
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* age 18-35
* untrained
* BMI: 20-25
Exclusion Criteria
* chronic diseases
* malignancy (former or present)
* alcohol, drug or EPO abuse
18 Years
35 Years
MALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Birgitte Nellemann
MD PhDstudent
Principal Investigators
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Britt Christensen, M.Sc., PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, Aarhus, Denmark
Department of Endocrinology, Research Laboratories
Aarhus, , Denmark
Countries
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References
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Larsen MS, Holm L, Svart MV, Hjelholt AJ, Bengtsen MB, Dollerup OL, Dalgaard LB, Vendelbo MH, van Hall G, Moller N, Mikkelsen UR, Hansen M. Effects of protein intake prior to carbohydrate-restricted endurance exercise: a randomized crossover trial. J Int Soc Sports Nutr. 2020 Jan 28;17(1):7. doi: 10.1186/s12970-020-0338-z.
Nielsen J, Christensen AE, Nellemann B, Christensen B. Lipid droplet size and location in human skeletal muscle fibers are associated with insulin sensitivity. Am J Physiol Endocrinol Metab. 2017 Dec 1;313(6):E721-E730. doi: 10.1152/ajpendo.00062.2017. Epub 2017 Jul 25.
Christensen B, Ludvigsen M, Nellemann B, Kopchick JJ, Honore B, Jorgensen JO. Serum proteomic changes after randomized prolonged erythropoietin treatment and/or endurance training: detection of novel biomarkers. PLoS One. 2015 Feb 13;10(2):e0117119. doi: 10.1371/journal.pone.0117119. eCollection 2015.
Other Identifiers
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M-20110035
Identifier Type: -
Identifier Source: org_study_id