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Heat Intolerance in the Group of FMF Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01059279
First received: January 28, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 28, 2010
January 28, 2010
December 2009
February 2010   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Heat Intolerance in the Group of FMF Patients
Heat Intolerance in the Group of FMF Patients

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, 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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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

  • Familial Mediterranean Fever
  • Heat Intolerance
  • Heat Tolerance Test
Not Provided
  • FMF patients
    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 people
    Healthy individuals, that participated in the study of Heller Institute of Medical Research.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • double mutations MEFV
  • mail
  • age from 18 to 30
  • colchicine treatment
  • absence of attack during 2 months

Exclusion Criteria:

  • individual wish
Male
18 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01059279
SHEBA-09-7575-AL-CTIL
No
Avi Livneh, Sheba Medical Center, Department of Internal Medicine
Sheba Medical Center
Not Provided
Principal Investigator: Avi Livneh, MD Sheba Medical Center
Sheba Medical Center
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP