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Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394238
First Posted: October 31, 2006
Last Update Posted: October 31, 2006
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:
Shaare Zedek Medical Center
  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
Time Perspective: Retrospective/Prospective

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Age below 18
  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): 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

ClinicalTrials.gov Identifier: NCT00394238     History of Changes
Other Study ID Numbers: 20174CTIL
First Submitted: October 29, 2006
First Posted: October 31, 2006
Last Update Posted: October 31, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Arthritis
Non-alcoholic Fatty Liver Disease
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Fatty Liver
Liver Diseases
Digestive System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases