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Trial record 33 of 127 for:    exosomes

Exosome Proteomics to Detect EPO

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ClinicalTrials.gov Identifier: NCT03700515
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
University of Tasmania
Information provided by (Responsible Party):
Morten Hostrup, PhD, University of Copenhagen

Brief Summary:
The role of exosomes in cell signalling has only recently been appreciated and is a hugely exciting and rapidly growing area, and combined with LC-MS/MS proteomics, can overcome traditional barriers to proteomics in doping applications. To our knowledge, no research has yet been undertaken to explore whether the highly promising combination of exosome proteomics has utility for rhEPO detection. The applications are extensive; the diagnostic value of differentially regulated proteins could be further validated against the existing IEF EPO WADA accredited tests using samples collected during this study, used to study altitude hypoxia versus exogenous EPO administration (WADA current targeted research 2017), investigated as a platform approach to ESA and HIF agents more generally, as well as facilitate development of direct ELISA high throughput tests.

Condition or disease Intervention/treatment Phase
Healthy Drug: Erythropoietin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Saline infusion
Drug: Placebo
Subjects receive weekly infusions of saline

Experimental: EPO
Erythropoetin infusion (9 IU/kg)
Drug: Erythropoietin
Subjects receive weekly infusions of EPO

Experimental: EPO II
Erythropoetin infusion (20 IU/kg)
Drug: Erythropoietin
Subjects receive weekly infusions of EPO




Primary Outcome Measures :
  1. Blood proteome enrichment pathway analysis in GO annotation [ Time Frame: At baseline and after week 3 of treatment ]
    Change in enrichment (measured in blood and assessed using GO annotation)


Secondary Outcome Measures :
  1. Blood markers of iron [ Time Frame: At baseline and after week 3 of treatment ]
    Change in blood markers of iron homeostasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • VO2max of at least 55+/-2 for men and 50+/-2 for women
  • BMI between 18 and 27
  • Resting hematocrit of less than 46%

Exclusion Criteria:

  • Chronic disease deemed by the medical doctor to affect the outcome
  • Competitive athlete subject to doping control
  • Use of other prescription medicine deemed by the medical doctor to interact with the study drug
  • Allergy or otherwise unacceptable side effects toward the study drug
  • Smoker
  • Pregnancy

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Responsible Party: Morten Hostrup, PhD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03700515     History of Changes
Other Study ID Numbers: EPO-EXO
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Morten Hostrup, PhD, University of Copenhagen:
EPO
Additional relevant MeSH terms:
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Epoetin Alfa
Hematinics