Drug Use and Ultra-endurance Race (Ultra-Trail)

• ClinicalTrials.gov Identifier: NCT03402022
• Recruitment Status: Completed
• First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Study Description

Brief Summary:

Hypothesis: To verify whether the use of drugs, in particular performance-enhancing drugs, is prevalent amongst participants in a very long distance mountain trail.

Primary objective : To qualify and quantify drug use amongst participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.

Condition or disease
Healthy Individuals

Detailed Description:

Introduction : very long distance mountain trail which is particularly demanding for the organism. This kind of competition is likely to have an impact on the athlete's health and / or physical integrity. It is assumed that many participants may use medication in an attempt to i) prevent and /or treat medical conditions induced by prolonged muscular exercise, and ii) delay fatigue and improve physical and/or psychological capacities. Beyond ethical and regulatory considerations, such practice in this isolated environment is not without health risks. However, to our knowledge, there is no objective data on medication use during very long distance mountain trails.

Methodology : Individual urine samples from male competitors participating in a very long distance mountain trail and using temporary urinals near the starting line will be collected within three hours before departure, anonymously, blindly, using hidden automated samplers. Simultaneously with automated urine sampling, demographic data (age class, ranking class, geographical area of residence, performance class over the year) will be collected anonymously via an automated system detecting the runners' electronic bibs. The quantification of different classes of drugs in the urine samples will be performed by World Anti-Doping Agency-accredited laboratories using liquid chromatography, mass spectrometry and / or gas chromatography. The classes of molecules sought will be the following: most common non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, stimulants, narcotics, anabolic agents, metabolic modulators, cannabinoids, beta2-agonists, beta-blockers, diuretics, benzodiazepines. A questionnaire about drug use before/during the race and using the randomized response technique (RRT) will be proposed online, anonymously to female and male participant after the competition.

Expected results : drug use is frequent amongst participants in a very long distance mountain trail. Drug use prevalence measured from automated urine collection is higher than that obtained from the RRT questionnaire.

Study Design

• Study Type: Observational
• Actual Enrollment: 2923 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection
• Actual Study Start Date: August 30, 2017
• Actual Primary Completion Date: December 15, 2017
• Actual Study Completion Date: December 15, 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. To measure urinary drug concentrations (in ng/ml) amongst male participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners. [ Time Frame: 18 months ]
   • sampling 466 individual urine specimens from male participants in a very long distance mountain trail;
   • measuring urinary concentrations of drugs belonging to the following classes : nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, stimulants, narcotics, anabolic agents, metabolic modulators, cannabinoids, beta2-agonists, beta-blockers, diuretics, benzodiazepines. Drug concentrations will be determined through liquid chromatography, mass spectrometry and / or gas chromatography, according to the molecules.

Secondary Outcome Measures :

1. To measure the responses (yes or no) to a questionnaire about drug use, amongst female and male participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners. [ Time Frame: 6 months ]
   - obtaining a return rate of at least 30% to the anonymous, online questionnaire proposed to the participants after their race.

Biospecimen Retention:   Samples Without DNA

466 urine samples have been collected

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals

Criteria

Inclusion Criteria:

• Automated urine collection : male participants starting a very long distance mountain trail.
• Questionnaire: female and male participants in a very long distance mountain trail.

Exclusion Criteria:

-

Contacts and Locations

Locations

France

UniversityHospitalGrenoble

Grenoble, France, 38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

• Principal Investigator: Pierre BOUZAT, Dr; University Hospital, Grenoble

More Information

Publications:

de Hon O, Kuipers H, van Bottenburg M. Prevalence of doping use in elite sports: a review of numbers and methods. Sports Med. 2015 Jan;45(1):57-69. doi: 10.1007/s40279-014-0247-x. Review.

Dietz P, Ulrich R, Dalaker R, Striegel H, Franke AG, Lieb K, Simon P. Associations between physical and cognitive doping--a cross-sectional study in 2.997 triathletes. PLoS One. 2013 Nov 13;8(11):e78702. doi: 10.1371/journal.pone.0078702. eCollection 2013.

McAnulty S, McAnulty L, Nieman D, Morrow J, Dumke C, Henson D. Effect of NSAID on muscle injury and oxidative stress. Int J Sports Med. 2007 Nov;28(11):909-15. Epub 2007 May 31.

Millet GY, Banfi JC, Kerherve H, Morin JB, Vincent L, Estrade C, Geyssant A, Feasson L. Physiological and biological factors associated with a 24 h treadmill ultra-marathon performance. Scand J Med Sci Sports. 2011 Feb;21(1):54-61. doi: 10.1111/j.1600-0838.2009.01001.x.

Robach P, Trebes G, Lasne F, Buisson C, Méchin N, Mazzarino M, de la Torre X, Roustit M, Kérivel P, Botré F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03402022
• Other Study ID Numbers: 38RC17.049; 2017-A00484-49 ( Other Identifier: ID RCB )
• First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Last Verified: January 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:

Sport; competition; ultra-endurance; trail running; doping