Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01059279
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2010-01-28
Brief Title:
Heat Intolerance in the Group of FMF Patients
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Heat Intolerance in the Group of FMF Patients
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to recruit patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There now causation between Heat Intolerance and FMF that were showed in studies till now We suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be significantly higher than in the group of healthy individuals that participated in the study of Heller Institute of Medical Research The aim of the study is verification of causation between these pathologies The information obtained by the study may allow us to determine the sequence of events associated with FMF attack development and perhaps take us one step further in the understanding of the pathogenesis of the disease
15 FMF patients with double mutations MEFV mail sex from the age from 18 to 30 without attacks during not less than 2 month will participate in the study To identify an individuals susceptibility to exercise heat test a Heat Tolerance Test HTT will perform according to HTT Protocol of Heller Institute of Medical Research
15 FMF patients with double mutations MEFV mail sex from the age from 18 to 30 without attacks during not less than 2 month will participate in the study To identify an individuals susceptibility to exercise heat test a Heat Tolerance Test HTT will perform according to HTT Protocol of Heller Institute of Medical Research
Detailed Description:
Familial Mediterranean fever FMF is a genetic disease caused by mutations in the FMF gene entitled MEFV The disease is characterized by painful attacks of inflammation in sites lined by serous membranes eg abdominal pain caused by inflammation of the peritoneum a serous membrane surrounding all internal organs within the abdomen fever during the attack Continuous colchicine treatment prevents attacks in most patients The pathogenesis of the disease what leads to the attacks is the questions not yet resolved We know that there is correlation between protein Pyrin and activity of Interleukin 1 IL1
Tolerance to sustain heat stress varies due to individual variation Under extreme conditions of exercise-heat stress even healthy well acclimated physically fit individuals will ultimately store heat at the rate that will cause body temperature to rise Individuals who are not able to sustain heat and whose body temperature will start rising earlier and at a higher rate than that of others under the same conditions are defined as heat intolerant
There now causation between Heat Intolerance and FMF that were showed in studies till now We suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be significantly higher than in the group of healthy individuals that participated in the study of Heller Institute of Medical Research The aim of the study is verification of causation between these pathologies The information obtained by the study may allow us to determine the sequence of events associated with FMF attack development and perhaps take us one step further in the understanding of the pathogenesis of the disease
15 FMF patients with double mutations MEFV male sex from the age from 18 to 30 without attacks during not less than 2 month will participate in the study To identify an individuals susceptibility to exercise heat test a Heat Tolerance Test HTT will perform according to HTT Protocol of Heller Institute of Medical Research
Tolerance to sustain heat stress varies due to individual variation Under extreme conditions of exercise-heat stress even healthy well acclimated physically fit individuals will ultimately store heat at the rate that will cause body temperature to rise Individuals who are not able to sustain heat and whose body temperature will start rising earlier and at a higher rate than that of others under the same conditions are defined as heat intolerant
There now causation between Heat Intolerance and FMF that were showed in studies till now We suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be significantly higher than in the group of healthy individuals that participated in the study of Heller Institute of Medical Research The aim of the study is verification of causation between these pathologies The information obtained by the study may allow us to determine the sequence of events associated with FMF attack development and perhaps take us one step further in the understanding of the pathogenesis of the disease
15 FMF patients with double mutations MEFV male sex from the age from 18 to 30 without attacks during not less than 2 month will participate in the study To identify an individuals susceptibility to exercise heat test a Heat Tolerance Test HTT will perform according to HTT Protocol of Heller Institute of Medical Research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None