Heat Intolerance in the Group of FMF Patients

NCT01059279 | Terminated

• 1 other identifier: SHEBA-09-7575-AL-CTIL
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Mediterranean Fever; Heat Intolerance; Heat Tolerance Test

Keywords

Familial Mediterranean fever; Cytokines; Inflammatory proteins; MEFV; mutations; Heat Intolerance; Heat Tolerance Test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• individual wish

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Avi Livneh, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: March 3, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IL (1)