Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00394238
First received: October 29, 2006
Last updated: October 30, 2006
Last verified: July 2006
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal

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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
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: NCT00394238

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

Locations
Israel
Rheumatoid Clinic Not yet recruiting
Jerusalem, Israel
Contact: Michal Mates, MD    0544727635    Mates@013.net   
Contact: Ornit Cohen, MSc    0507867234    bionet@017.net.il   
Principal Investigator: Michal Mates, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Michal Mates, MD Shaare Zedek Medical Center Jerusalem
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 20, 2014