Inflammatory ResponseTRAIL PHYSIONCT03256006

Study Inflammation During a 100 Miles

An observational study of Inflammatory Response, run by Hôpital Necker-Enfants Malades.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

To study per and post effort variations of inflammatory biological markers during a 100 miles Read more about this study

Who is it for?: Ages 18 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for: Inflammatory Response
What is being tested?: Blood sample
How many people: 20 participants
Where: No sites listed yet
Study dates: 18 Oct 2018to 29 Oct 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: Healthy volunteers

Who may be able to join

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

Who cannot join

female
age<18years

About this study

Official title: Per Effort Study of Inflammation During a 100 Miles

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

Conditions: Inflammatory Response
Being tested: Blood sample
Keywords: sport exercise, ultra endurance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

Variation per and post effort of interleukin 1 plasma level
Plasma level of per and post effort of interleukin 1 will be measured
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
Plasma level of per and post effort of interleukin 6 will be measured
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
Plasma level of per and post effort of protein C reactive will be measured
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
Plasma level of per and post effort of tumor necrosis alpha will be measured
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
Plasma level of per and post effort of interleukin 4 will be measured
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
Plasma level of per and post effort of interleukin 10 will be measured
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
Plasma level of per and post effort of interleukin 13 will be measured
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
Plasma level of per and post effort of tumor growth factor beta
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 lipids plasma level
Plasma level of per and post effort of lipids
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 lipoproteins plasma level
Plasma level of per and post effort of lipoproteins
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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 201829 Oct 2018

First posted21 Aug 2017
Study start18 Oct 2018 (estimated)
Primary completion18 Oct 2018 (estimated)
Study completion29 Oct 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03256006
Sponsor's protocol ID: 2017-A02397-46
Acronym: TRAIL PHYSIO
Status last verified: Aug 2018
First submitted: 10 Aug 2017
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Inflammatory Response trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Per Effort Study of Inflammation During a 100 Miles
ClinicalTrials.gov ID: NCT03256006
Acronym / sponsor ID: TRAIL PHYSIO / 2017-A02397-46
Conditions: Inflammatory Response
Keywords: sport exercise, ultra endurance
Study type: Observational
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Hôpital Necker-Enfants MaladesUniversity, hospital or other
Study start: 18 Oct 2018 (estimated)
Primary completion: 18 Oct 2018 (estimated)
Study completion: 29 Oct 2018 (estimated)
First posted: 21 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy volunteers

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

female
age<18years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood sampleBlood sample to study per and post effort evolution markers of systemic inflammation	Other	–

Primary outcome

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
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
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
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
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
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
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
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
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
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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Individual participant dataSharing planned: Undecided

Related trials for Inflammatory Response

Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingPhase 4
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Crohn Disease
RecruitingPhase 3
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
Sepsis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Response, run by Hôpital Necker-Enfants Malades.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.