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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
  Purpose

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
Familial Mediterranean Fever
Heat Intolerance
Heat Tolerance Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heat Intolerance in the Group of FMF Patients

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • individual wish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059279

Locations
Israel
Sheba Medical Center
Tel Hashomer., Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Avi Livneh, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Avi Livneh, Sheba Medical Center, Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT01059279     History of Changes
Other Study ID Numbers: SHEBA-09-7575-AL-CTIL
Study First Received: January 28, 2010
Last Updated: January 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Familial Mediterranean fever
Cytokines
Inflammatory proteins
MEFV
mutations
Heat Intolerance
Heat Tolerance Test

Additional relevant MeSH terms:
Brucellosis
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Bacterial Infections
Genetic Diseases, Inborn
Gram-Negative Bacterial Infections
Skin Diseases
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 27, 2014