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Biological Consequences of an Ultra Endurance Race (TRAIL-BIO)

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ClinicalTrials.gov Identifier: NCT03194022
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Romain Jouffroy, Hôpital Necker-Enfants Malades

Brief Summary:
The aim is to study per and post-exertion variations of biological markers during an ultra-endurance race

Condition or disease Intervention/treatment
Exertion; Excess Other: Blood sample

Detailed Description:
25 healthy adult volunteers participating in the "100 miles South of France 2017©" race recruited electronically by an announcement on the race website

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Per Effort Study of Biological Consequences of an Ultra Endurance Race (165km)
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 17, 2018

Intervention Details:
  • Other: Blood sample
    measurement of electrolytes and blood count


Primary Outcome Measures :
  1. Per and post-exertion evolution of sodium blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of sodium blood level during and after the race will be measured.

  2. Per and post-exertion evolution of lactatemia [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of lactatemia during and after the race will be measured.

  3. Per and post-exertion evolution of myoglobin blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of myoglobin blood level will be measured during and after the race

  4. Per and post-exertion evolution of creatinine phosphokinase blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of myoglobin blood level will be measured during and after the race

  5. Per and post-exertion evolution of potassium blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of potassium blood level during and after the race will be measured.

  6. Per and post-exertion evolution of chlorine blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of chlorine blood level during and after the race will be measured.

  7. Per and post-exertion evolution of glucose blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of glucose blood level during and after the race will be measured.

  8. Per and post-exertion evolution of calcium blood level [ Time Frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race ]
    Change of calcium blood level during and after the race will be measured.


Biospecimen Retention:   Samples Without DNA
blood electrolytes


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
25 healthy adult volunteers participating in the "100 miles South of France 2017 ©" race recruited electronically by an announcement on the race website
Criteria

Inclusion Criteria:

  1. Age greater 18 years.
  2. Subject having already completed an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.
  3. Affiliation of a social security.

Exclusion Criteria:

  1. Age lower than 18 years
  2. Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or having a significant chronic inflammatory disease known at the time of the inclusion visit the day before the race.
  3. Female

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Responsible Party: Romain Jouffroy, Principal Investigator, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT03194022     History of Changes
Other Study ID Numbers: IDRCB : 2017-A01801-52
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
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