Identification of New Serum Markers for Detection of Abuse With Erythropoietin
1 other identifier
interventional
35
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 1, 2012
July 1, 2012
11 months
March 18, 2011
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in substrate metabolism in relation to rHuEpo treatment and endurance training
10 months
Study Arms (4)
No training + placebo
PLACEBO COMPARATOR10 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.
No training + EPO
ACTIVE COMPARATOR10 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.
Training + placebo
ACTIVE COMPARATOR10 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 + EPO
ACTIVE COMPARATOR10 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.
Interventions
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.
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 (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
You may qualify if:
- healthy men
- age 18-35
- untrained
- BMI: 20-25
You may not qualify if:
- smokers
- chronic diseases
- malignancy (former or present)
- alcohol, drug or EPO abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus, Aarhus, 8000, Denmark
Department of Endocrinology, Research Laboratories
Aarhus, 8000, Denmark
Related Publications (3)
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.
PMID: 31992300DERIVEDNielsen 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.
PMID: 28743757DERIVEDChristensen 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.
PMID: 25679398DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Britt Christensen, M.Sc., PhD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhDstudent
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 22, 2011
Study Start
August 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 1, 2012
Record last verified: 2012-07