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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03256006
Other study ID # 2017-A02397-46
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 18, 2018
Est. completion date October 29, 2018

Study information

Verified date August 2018
Source Hôpital Necker-Enfants Malades
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date October 29, 2018
Est. primary completion date October 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- adults (age>18years)

- completion of an ultra endurance race (50 miles) during the 2 years before

Exclusion Criteria:

- female

- age<18years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sample
Blood sample to study per and post effort evolution markers of systemic inflammation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Necker-Enfants Malades

Outcome

Type Measure Description Time frame Safety issue
Primary Variation per and post effort of interleukin 1 plasma level 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
Primary Variation per and post effort of interleukin 6 plasma level 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
Primary Variation of per and post effort of protein C reactive 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
Primary Variation per and post effort of interleukin Tumor Necrosis Factor alpha 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
Primary Variation per and post effort of interleukin 4 plasma level 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
Primary Variation per and post effort of interleukin 10 plasma level 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
Primary Variation per and post effort of interleukin 13 plasma level 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
Primary Variation per and post effort of interleukin tumor growth factor beta plasma level 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
Primary Variation per and post effort of lipids plasma level 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
Primary Variation per and post effort of lipoproteins plasma level 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
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