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Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis
This study is not yet open for participant recruitment.
Verified by Shaare Zedek Medical Center, July 2006
First Received: October 29, 2006   Last Updated: October 30, 2006   History of Changes
Sponsored by: Shaare Zedek Medical Center
Information provided by: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00394238
  Purpose

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 Intervention
Arthritis, Rheumatoid
Procedure: Ultrasonographic imaging

MedlinePlus related topics: Liver Diseases Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study

Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 50
Study Start Date: November 2006
Estimated Study Completion Date: October 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Age below 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394238

Contacts
Contact: Ornit Cohen, Msc 0507867234 bionet@017.net.il

Locations
Israel
Rheumatoid Clinic
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Michal Mates, MD Shaare Zedek Medical Center Jerusalem
  More Information

No publications provided

Study ID Numbers: 20174CTIL
Study First Received: October 29, 2006
Last Updated: October 30, 2006
ClinicalTrials.gov Identifier: NCT00394238     History of Changes
Health Authority: Israel: Ethics Commission

Study placed in the following topic categories:
Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Fatty Liver
Rheumatic Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009