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

Completed

• Conditions: Ultra-trail Participation

• Registration Number: NCT03205098
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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 Timeline

• Study Start: 2015-06-19
• Primary Completion: 2015-06-30
• Study Completion: 2016-09-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess biological markers of mesenteric ischemia (IFABP)	at day 1	during ultratrail.

Secondary Outcome Measures

Name	Time	Method
Relationship between digestive symptoms and biological markers (IFABP).	at day 1

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France