Heat Intolerance in the Group of FMF Patients

Sponsor

Sheba Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01059279

Collaborator

(none)

Enrollment

Location

192

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Familial Mediterranean Fever Heat Intolerance Heat Tolerance Test

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".

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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Heat Intolerance in the Group of FMF Patients

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Rate of heat intolerance defined by the HTT protocol of Heller Institute of Medical Research. [At the end of the test - One day test]
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