NCT03194022

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

June 16, 2017

Last Update Submit

August 1, 2018

Conditions

Exertion; Excess

Outcome Measures

Primary Outcomes (8)

  • Per and post-exertion evolution of sodium blood level

    Change of sodium blood level during and after the race will be measured.

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of lactatemia

    Change of lactatemia during and after the race will be measured.

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of myoglobin blood level

    Change of myoglobin blood level will be measured during and after the race

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of creatinine phosphokinase blood level

    Change of myoglobin blood level will be measured during and after the race

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of potassium blood level

    Change of potassium blood level during and after the race will be measured.

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of chlorine blood level

    Change of chlorine blood level during and after the race will be measured.

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of glucose blood level

    Change of glucose blood level during and after the race will be measured.

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertion evolution of calcium blood level

    Change of calcium blood level during and after the race will be measured.

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

Interventions

Blood sampleOTHER

measurement of electrolytes and blood count

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Age lower than 18 years
  • Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood electrolytes

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 21, 2017

Study Start

October 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 17, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08