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Clinical Trials/NCT01095042
NCT01095042
Completed
N/A

Etude de la réactivité émotionnelle Des Patients MICI ou SII

University Hospital, Grenoble1 site in 1 country120 target enrollmentOctober 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
University Hospital, Grenoble
Enrollment
120
Locations
1
Primary Endpoint
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.

Detailed Description

The objective of the study which we wish to lead consists in looking for, at the patients SII and IBD in forgiveness, the existence of a correlation between the rate of cortisol(Hormone of the stress) and the level of HRV (Heart Rate Variability) to estimate the inhibitive fronto-amygdalien tonus. So we make the hypothesis that the persons affected by digestive pathologies of type SII or IBD would present an emotional and physiological vulnerability more important than unhurt subjects of pathologies.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with SII :Membership to the Social Security,SII defined according to the criteria Rome III.
  • Patients with IBD :Membership to the Social Security,patients with a ulcerative colitis(UC) or a Crohn's disease (CD)ileal and/or colic.

Exclusion Criteria

  • Existence of a severe affectation on the general plan (cardiac,respiratory,hematological,renal,hepatic,cancerous),
  • Subject diabetic,
  • Pregnant or breast-feeding woman,
  • Subject included in another clinical and\\or therapeutic trial or having been included in a clinical and\\or therapeutic trial for less than a month,
  • Subject presenting a psychiatric pathology evident,
  • Person under guardianship.

Outcomes

Primary Outcomes

RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY

Time Frame: 24 MONTHS

Secondary Outcomes

  • SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.(24 MONTHS)

Study Sites (1)

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