Ultra-trail ParticipationISKETRAILNCT03205098
Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail
An observational study of Ultra-trail Participation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
To assess the evolution of biological markers of mesenteric ischemia during ultratrail. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultra-trail Participation
- What is being tested?
- Blood analysis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2015to 30 Sep 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants or populations are selected based on predefined criteria
Who may be able to join
- Healthy Voluntary Subject
- Age > 18 years
- Written consent
- Subject affiliated to Social Security
- Medical certificate (mandatory to take part in the ultra-trail)
Who cannot join
- Refusal to participate
- Subject with legal protection (guardianship, trusteeship)
Trial locations and contacts
1 site in 1 country.
About this study
To assess the evolution of biological markers of mesenteric ischemia during ultratrail.
Read the detailed description
During physical exercise, increased sympathetic nervous system activity redistributes blood flow from splanchnic organs to working muscles. With prolonged duration and / or intensity, the splanchnic blood flow can be reduced by 80% or more. A severely reduced of splanchnic blood flow can frequently cause gastrointestinal ischemia. This ischemia associated with reduced vagal activity probably results in changes in motility and absorption.
High symptoms are reported in 40% of runners with reflux and heartburn in 15-20% of runners. The low symptoms have an incidence of about 70% in the long runs type ultra-trail.
Biological markers such as I-FABP have been shown to be useful in the diagnosis of mesenteric ischemia.
- Conditions
- Ultra-trail Participation
- Being tested
- Blood analysis
- Keywords
- biological markers, mesenteric ischemia, ultratrail
- Medical subject headings
- Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood analysisBiological
Blood test of biological markers of mesenteric ischemia
| Study group | Role | What they receive |
|---|---|---|
| Runners | To assess the evolution of biological markers of mesenteric ischemia during ultratrail. Receives: Biological: Blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess biological markers of mesenteric ischemia (IFABP)
during ultratrail.
Measured: at day 1
Secondary outcomes (1)
Relationship between digestive symptoms and biological markers (IFABP).
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start19 Jun 2015
- Primary completion30 Jun 2015
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-trail ParticipationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205098
- Sponsor's protocol ID
- CHU-340
- Other IDs
- 2015-A00470-49
- Acronym
- ISKETRAIL
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail
- ClinicalTrials.gov ID
- NCT03205098
- Acronym / sponsor ID
- ISKETRAIL / CHU-340
- Conditions
- Ultra-trail Participation
- Keywords
- biological markers, mesenteric ischemia, ultratrail
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 2 Jul 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 assess the evolution of biological markers of mesenteric ischemia during ultratrail.
Detailed description
During physical exercise, increased sympathetic nervous system activity redistributes blood flow from splanchnic organs to working muscles. With prolonged duration and / or intensity, the splanchnic blood flow can be reduced by 80% or more. A severely reduced of splanchnic blood flow can frequently cause gastrointestinal ischemia. This ischemia associated with reduced vagal activity probably results in changes in motility and absorption.
High symptoms are reported in 40% of runners with reflux and heartburn in 15-20% of runners. The low symptoms have an incidence of about 70% in the long runs type ultra-trail.
Biological markers such as I-FABP have been shown to be useful in the diagnosis of mesenteric ischemia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Runners | – | Biological: Blood analysisTo assess the evolution of biological markers of mesenteric ischemia during ultratrail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants or populations are selected based on predefined criteria
Key inclusion criteria (5 listed)
- Healthy Voluntary Subject
- Age > 18 years
- Written consent
- Subject affiliated to Social Security
- Medical certificate (mandatory to take part in the ultra-trail)
Key exclusion criteria (2 listed)
- Refusal to participate
- Subject with legal protection (guardianship, trusteeship)
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 analysisBlood test of biological markers of mesenteric ischemia | Biological | Runners |
Primary outcome
Assess biological markers of mesenteric ischemia (IFABP)
Time frame: at day 1
during ultratrail.
1 secondary outcome
Relationship between digestive symptoms and biological markers (IFABP).
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultra-trail Participation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess biological markers of mesenteric ischemia (IFABP) (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.