Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05679648
Collaborator
(none)
100
5

Study Details

Study Description

Brief Summary

studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasonography

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients: a Cross-sectional Case-control Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Rheumatoid arthritis patients

Diagnostic Test: ultrasonography
studying degree of steatosis

control

Diagnostic Test: ultrasonography
studying degree of steatosis

Outcome Measures

Primary Outcome Measures

  1. degree of hepatic steatosis [1 day during examination]

    degree of hepatic steatosis by ultrasonography and Hepatic Steatosis Index.

  2. degree of hepatic fibrosis [1 day during examination]

    degree of hepatic fibrosis by FIB-4 and APRI tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)

  2. Age≥18 years

Exclusion Criteria:
  • History of hepatitis B and C virus infection.

  • Receiving hepatotoxic drugs other than RA-specific drugs.

  • Alcohol abuse (i30 g/day in men and ⩾20 g/day in women).

  • Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis.

  • Autoimmune liver disease.

  • Cancer.

  • Pregnancy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Hamed, Lecturer, Sohag University
ClinicalTrials.gov Identifier:
NCT05679648
Other Study ID Numbers:
  • Soh-Med-22-11-17
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amr Hamed, Lecturer, Sohag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023