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Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

NCT ID: NCT00394238

Last Updated: 2006-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-10-31

Brief Summary

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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

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Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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Ultrasonographic imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid arthritis

Exclusion Criteria

* Age below 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Michal Mates, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center Jerusalem

Locations

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Rheumatoid Clinic

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ornit Cohen, Msc

Role: CONTACT

Phone: 0507867234

Email: [email protected]

Facility Contacts

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Michal Mates, MD

Role: primary

Ornit Cohen, MSc

Role: backup

Other Identifiers

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20174CTIL

Identifier Type: -

Identifier Source: org_study_id