Clinical trial NCT01320449: Identification of New Serum Markers for Detection of Abuse With Erythropoietin
Official title: Identification of New Serum Markers for Detection of Abuse With Erythropoietin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse Problem
Keywords: EPO
Proteomics
Carbohydrate metabolism
Fat metabolism
Protein metabolism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in serum protein isoforms measured by proteomics
timeFrame: 10 months
Secondary outcomes:
measure: Changes in substrate metabolism in relation to rHuEpo treatment and endurance training
timeFrame: 10 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Department of Endocrinology, Research Laboratories
Study officials:
affiliation: Aarhus University Hospital
name: Britt Christensen, M.Sc., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.