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Heat Intolerance in the Group of FMF Patients

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059279
First Posted: January 29, 2010
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof.Avi Livneh, Sheba Medical Center
  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 Prof.Avi Livneh, Sheba Medical Center:

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof.Avi Livneh, Professor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01059279     History of Changes
Other Study ID Numbers: SHEBA-09-7575-AL-CTIL
First Submitted: January 28, 2010
First Posted: January 29, 2010
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Prof.Avi Livneh, 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
Gram-Negative Bacterial Infections
Bacterial Infections
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases