Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01059279
Other study ID # SHEBA-09-7575-AL-CTIL
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT00658060 - Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients N/A
Withdrawn NCT05448391 - A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF) Phase 2
Recruiting NCT05190991 - Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Phase 2
Completed NCT00094900 - Interleukin-1 Trap to Treat Autoinflammatory Diseases Phase 2
Not yet recruiting NCT06033339 - Assessment of microRNAs Role in Familial Mediterranean Fever FMF Pathophysiology N/A
Completed NCT01705756 - Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever Phase 3
Recruiting NCT06338891 - Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Recruiting NCT05596643 - Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever
Enrolling by invitation NCT02175589 - Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation Phase 2
Completed NCT05177120 - Central Sensitization in Familial Mediterranean Fever (FMF)
Active, not recruiting NCT06257342 - Physical Abilities of Teenagers With Familial Mediterranean Fever
Recruiting NCT04478409 - Characterization of a Functional Test for Mediterranean Family Fever Screening - 2
Recruiting NCT06034795 - Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever
Completed NCT04729218 - The Movement Imagery Ability in Patients With Familial Mediterranean Fever
Enrolling by invitation NCT04724993 - Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever N/A
Completed NCT03747315 - A Diagnostic Test for Familial Mediterranean Fever
Completed NCT01075906 - Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients Phase 1
Withdrawn NCT00323440 - Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission N/A
Completed NCT00582907 - Rilonacept for Treatment of Familial Mediterranean Fever (FMF) Phase 2
Not yet recruiting NCT05488561 - Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings N/A