- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320449
Identification of New Serum Markers for Detection of Abuse With Erythropoietin
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aarhus, Denmark, 8000
- Aarhus University Hospital
-
Aarhus, Denmark, 8000
- Department of Endocrinology, Research Laboratories
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in serum protein isoforms measured by proteomics
Time Frame: 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.
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in substrate metabolism in relation to rHuEpo treatment and endurance training
Time Frame: 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.
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10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Britt Christensen, M.Sc., PhD, Aarhus University Hospital
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20110035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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