CClinicalTrials.gg
CompletedNCT03205098ISKETRAILUpdated Jul 2, 2017

Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail

An observational study in Ultra-trail Participation, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ultra-trail Participation

Keywords

  • biological markers
  • mesenteric ischemia
  • ultratrail
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

participants or populations are selected based on predefined criteria

Inclusion criteria

  • Healthy Voluntary Subject
  • Age > 18 years
  • Written consent
  • Subject affiliated to Social Security
  • Medical certificate (mandatory to take part in the ultra-trail)

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • Subject with legal protection (guardianship, trusteeship)
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Runners

    To assess the evolution of biological markers of mesenteric ischemia during ultratrail.

    Biological: Blood analysis

Interventions

  • BiologicalBlood analysis

    Blood test of biological markers of mesenteric ischemia

05

What researchers measure

Primary outcomes

  1. Assess biological markers of mesenteric ischemia (IFABP)

    during ultratrail.

    Time frame: at day 1

Secondary outcomes

  1. Relationship between digestive symptoms and biological markers (IFABP).

    Time frame: at day 1

06

Study locations

1 site
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, Auvergne 63003, France
07

Registry details

Key details

Study ID
NCT03205098
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Jul 2, 2017
Start date
Jun 19, 2015
Primary completion
Jun 30, 2015
Completion
Sep 30, 2016
Last update
Jul 2, 2017

Study contacts

Sébastien PERBET
principal investigator · CHU de Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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