Study Inflammation During a 100 Miles

Inflammatory Response Clinical Trial

— TRAIL PHYSIO  

Official title:

Per Effort Study of Inflammation During a 100 Miles

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03256006
• Other study ID #: 2017-A02397-46
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Response

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