Studying Non Alcoholic Fatty Liver Disease and Liver Fibrosis Among Systemic Lupus Erythematosus Patients At Assiut University Hospital

NCT06601361 | Not Yet Recruiting

• 1 other identifier: NAFLD in SLE
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of the study :-

1. 1.to estimate prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients
2. 2.to determine risk factors in SLE patients contributing to NAFLD and liver fibrosis

Conditions

NAFLD - Nonalcoholic Fatty Liver Disease

Keywords

NAFLD and SLE

Outcome Measures

Primary Outcomes (1)

• estimation of prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients

  We will divide lupus patients into 3 groups group number 1 who are SLE patient in activity and not taking treatment,group number 2 who are SLE patients in activity and taking treatment and controlled,group number 3 who are SLE patients in activity and taking treatment but not controlled our outcome is to estimate prevalence of NAFLD in each group .

  baseline

Secondary Outcomes (1)

• determinate risk factors in SLE patients contributing to NAFLD and liver fibrosis

  baseline

Interventions

Fibroscan DEVICE

Fibroscan (transient elastography ) is a non-invasive imaging method that evaluates steatosis and fibrosis by measuring liver stiffness using ultrasonographic sound waves. It is an acceptable alternative to liver biopsy and is fast , reliable, and reproducible, enabling screening and disease follow-up.11 It is now widely used to assess liver fibrosis in various liver diseases; however, currently there is no data on Fibroscan assessment regarding hepatic involvement in SLE patients. The aim of this study was to evaluate fatty liver and liver fibrosis in SLE patients using fibroscan and determine associated factors such as immunosuppressive medications.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years old ,Both sex male and female, diagnosed with SLE

You may qualify if:

• Adult patients aged 18 years old ,Both sex male and female, diagnosed with SLE

You may not qualify if:

• Age below 18 years old
• patients with hepatitis b virus (HBV), hepatitis c virus (HCV) or cirrhosis
• malignancy, cardiac disease,
• patients on dialysis.
• obese patient, BMI more than 30

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Yetginoglu O, Atas DB, Yilmaz Y, Velioglu A, Arikan H, Alibaz-Oner F, Direskeneli H, Tuglular S, Asicioglu E. Fibroscan detection of fatty liver and liver fibrosis in patients with systemic lupus erythematosus. Lupus. 2022 May;31(6):723-729. doi: 10.1177/09612033221094708. Epub 2022 Apr 10.

  PMID: 35403493 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ayman Makram Ayad, physician

CONTACT

+20 01070387266; Aimen.16266102@med.aun.edu.eg

Mohammad Alyamany kobeisy, prof

CONTACT

01002228914; Yamany1@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09