Study Inflammation During a 100 Miles (TRAIL PHYSIO)

August 1, 2018 updated by: Romain Jouffroy, Hôpital Necker-Enfants Malades

Per Effort Study of Inflammation During a 100 Miles

To study per and post effort variations of inflammatory biological markers during a 100 miles

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

  • adults (age>18years)
  • completion of an ultra endurance race (50 miles) during the 2 years before

Exclusion Criteria:

  • female
  • age<18years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation per and post effort of interleukin 1 plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of interleukin 1 will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of interleukin 6 plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of interleukin 6 will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation of per and post effort of protein C reactive
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of protein C reactive will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of interleukin Tumor Necrosis Factor alpha
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of tumor necrosis alpha will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of interleukin 4 plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of interleukin 4 will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of interleukin 10 plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of interleukin 10 will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of interleukin 13 plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of interleukin 13 will be measured
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of interleukin tumor growth factor beta plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of tumor growth factor beta
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of lipids plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of lipids
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Variation per and post effort of lipoproteins plasma level
Time Frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
Plasma level of per and post effort of lipoproteins
Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Necker-Enfants Malades

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 18, 2018

Primary Completion (Anticipated)

October 18, 2018

Study Completion (Anticipated)

October 29, 2018

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02397-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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