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Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00394238
Collaborator
(none)
50
Enrollment
1
Location
23
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide distribution and can affect all age group. The peak incidence is between fourth and sixth decade. It is more prevalent in women, and it's prevalence in the general population in North America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease in families and high concordance in mono-zydotic twins support genetic predisposition. The prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown. We wish to study the link between the two conditions by performing a son graphic imaging of the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in the RA patients, further support will be landed for the link between inflammation and fatty liver disease. These findings may also have implications regarding the management and follow up of RA patients.

The validity of sonographic imaging for detection of fatty liver diseases is currently accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89% and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and 89% respectively in detecting increase fibrosis.

In view of all the above data, we expected to find higher prevalence of fatty liver in the patients with higher inflammation markers compare with patients with lower markers.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasonographic imaging

Study Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Other
Study Start Date :
Nov 1, 2006
Study Completion Date :
Oct 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Rheumatoid arthritis
    Exclusion Criteria:
    • Age below 18

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheumatoid Clinic Jerusalem Israel

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

    • Principal Investigator: Michal Mates, MD, Shaare Zedek Medical Center Jerusalem

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00394238
    Other Study ID Numbers:
    • 20174CTIL
    First Posted:
    Oct 31, 2006
    Last Update Posted:
    Oct 31, 2006
    Last Verified:
    Jul 1, 2006
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Oct 31, 2006