Heat Intolerance in the Group of FMF Patients

NCT ID: NCT01059279

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2024-03-03

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.

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, 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.

Conditions

Familial Mediterranean Fever; Heat Intolerance; Heat Tolerance Test

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

healthy people

Healthy individuals, that participated in the study of Heller Institute of Medical Research.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• individual wish

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof.Avi Livneh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avi Livneh, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

SHEBA-09-7575-AL-CTIL

Identifier Type: -

Identifier Source: org_study_id