Heat Intolerance in the Group of FMF Patients

Familial Mediterranean Fever Clinical Trial

Official title:

Heat Intolerance in the Group of FMF Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01059279
• Other study ID #: SHEBA-09-7575-AL-CTIL
• Status: Terminated
• 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
• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 3, 2024
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• double mutations MEFV

• mail

• age from 18 to 30

• colchicine treatment

• absence of attack during 2 months

Exclusion Criteria:

• individual wish

Related Conditions & MeSH terms

• Brucellosis
• Familial Mediterranean Fever
• Heat Intolerance
• Heat Tolerance Test
• Hereditary Autoinflammatory Diseases

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer.

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the end of the test - One day test