An observational study in Familial Mediterranean Fever, Heat Intolerance and Heat Tolerance Test, sponsored by Sheba Medical Center. Terminated at 1 site in Israel. Open to male participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Sheba Medical Center · Observational
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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.
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.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
This study's enrollment of 7 is below the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.
Browse Familial Mediterranean Fever studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
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15 FMF patients with double mutations MEFV, mail sex, from the age from 18 to 30. treated with colchicine, without attacks not less than 2 months
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Exclusion Criteria:
15 FMF patients with double mutations MEFV, mail sex, from the age from 18 to 30. treated with colchicine, without attacks not less than 2 months
Healthy individuals, that participated in the study of Heller Institute of Medical Research.
Rate of heat intolerance defined by the HTT protocol of Heller Institute of Medical Research.
Number of patients who failed the HTT divided by number of patients undergoing the test. Failure to finished the test for reasons other than a rise in the temperature will be excluded
Time frame: At the end of the test - One day test
The record gives a start of Dec 2009, a primary completion of Aug 2012 and a completion of Mar 2024. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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