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

Ultra-trail Participation Clinical Trial

— ISKETRAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205098
• Other study ID #: CHU-340
• Secondary ID: 2015-A00470-49
• Status: Completed
• Phase: N/A
• First received: June 21, 2017
• Last updated: June 29, 2017
• Start date: June 19, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: June 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2016
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Mesenteric Ischemia
• Ultra-trail Participation

Intervention

Biological:
• Blood analysis
Blood test of biological markers of mesenteric ischemia

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess biological markers of mesenteric ischemia (IFABP)	during ultratrail.	at day 1
Secondary	Relationship between digestive symptoms and biological markers (IFABP).		at day 1