Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT01059279 |
Other study ID # |
SHEBA-09-7575-AL-CTIL |
Secondary ID |
|
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 2009 |
Est. completion date |
March 3, 2024 |
Study information
Verified date |
March 2024 |
Source |
Sheba Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 (e.g. 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.