Heat Intolerance in the Group of FMF Patients
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Familial Mediterranean Fever; Heat Intolerance; Heat Tolerance Test
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Avi Livneh, MD, Principal Investigator, Affiliation: Sheba Medical Center
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.
Clinical Details
Official title: Heat Intolerance in the Group of FMF Patients
Study design: Observational Model: Case-Only, Time Perspective: Prospective
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 (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, 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- double mutations MEFV
- mail
- age from 18 to 30
- colchicine treatment
- absence of attack during 2 months
Exclusion Criteria:
- individual wish
Locations and Contacts
Sheba Medical Center, Tel Hashomer. 52621, Israel
Additional Information
Starting date: December 2009
Last updated: January 28, 2010
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