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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00394238
Other study ID # 20174CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 29, 2006
Last updated October 30, 2006
Start date November 2006
Est. completion date October 2008

Study information

Verified date July 2006
Source Shaare Zedek Medical Center
Contact Ornit Cohen, Msc
Phone 0507867234
Email bionet@017.net.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date October 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Rheumatoid arthritis

Exclusion Criteria:

- Age below 18

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasonographic imaging


Locations

Country Name City State
Israel Rheumatoid Clinic Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

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