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Identification of New Serum Markers for Detection of Abuse With Erythropoietin

Primary Purpose

Substance Abuse Problem

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
recombinant human erythropoietin
Training
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Substance Abuse Problem focused on measuring EPO, Proteomics, Carbohydrate metabolism, Fat metabolism, Protein metabolism

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University Hospital
  • Department of Endocrinology, Research Laboratories

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

No training + placebo

No training + EPO

Training + placebo

Training + EPO

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in substrate metabolism in relation to rHuEpo treatment and endurance training
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.

Full Information

First Posted
March 18, 2011
Last Updated
July 31, 2012
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01320449
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse Problem
Keywords
EPO, Proteomics, Carbohydrate metabolism, Fat metabolism, Protein metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No training + placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
No training + EPO
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training + placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training + EPO
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
recombinant human erythropoietin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in serum protein isoforms measured by proteomics
Description
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.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Changes in substrate metabolism in relation to rHuEpo treatment and endurance training
Description
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.
Time Frame
10 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Christensen, M.Sc., PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of Endocrinology, Research Laboratories
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31992300
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.
Results Reference
derived
PubMed Identifier
28743757
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.
Results Reference
derived
PubMed Identifier
25679398
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.
Results Reference
derived

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Identification of New Serum Markers for Detection of Abuse With Erythropoietin

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