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Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00394238
Recruitment Status : Unknown
Verified July 2006 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2006
Last Update Posted : October 31, 2006
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date October 29, 2006
First Posted Date October 31, 2006
Last Update Posted Date October 31, 2006
Study Start Date November 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Arthritis, Rheumatoid
Intervention Procedure: Ultrasonographic imaging
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: October¬†30,¬†2006)
50
Original Enrollment Same as current
Study Completion Date October 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Age below 18
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00394238
Other Study ID Numbers 20174CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Shaare Zedek Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Michal Mates, MD Shaare Zedek Medical Center Jerusalem
PRS Account Shaare Zedek Medical Center
Verification Date July 2006