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NAFLD - Nonalcoholic Fatty Liver DiseaseNAFLD and SLENCT06601361

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

An observational study of NAFLD - Nonalcoholic Fatty Liver Disease, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim of the study :- 1. to estimate prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients 2. to determine risk factors in SLE patients contributing to NAFLD and liver fibrosis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NAFLD - Nonalcoholic Fatty Liver Disease
What is being tested?
Fibroscan
Type of treatment
Medical device
How many people
112 participants
Where
No sites listed yet
Study dates
1 Oct 2024to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Ayman Makram Ayad, physician contact

+20 01070387266

Aimen.16266102@med.aun.edu.eg

Mohammad Alyamany kobeisy, prof contact

01002228914

Yamany1@med.aun.edu.eg

About this study

Aim of the study :-

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

Lupus Erythematosus (SLE) is a systemic, multi organ, Autoimmune disease that more common in women than men and is typically diagnosed during the reproductive age .1 Lupus affects almost all organs and can present with awide variety of symptoms . Renal and skin involvement are the most frequently encountered presentation ,however gastrointestinal involvement is also seen in patients with SLE.2 involvement of liver in SLE is rare and mostly presents as asymptomatic hepatomegaly subclinical adiposity, and/or increased liver enzymes.3.4 Elevated transaminase levels may be observed in 15-55% of the patient population and can be associated with disease activity.4,5 The most common causes are drug-related liver injury (31%), lupus-associated hepatitis (29%), and fatty liver disease (18%).6 drugs used in the treatment of SLE patient such as non-steroidal anti-inflammatory drugs, glucocorticoids, cyclophosphamide ,mycophenolate mofetil, azathioprine, and methotrexate can all cause hepatotoxicity.7 As such, it is important to differentiate the etiology and determine whether hepatotoxicity is due to the medications used or the disease itself.

Non-alcoholic fatty liver disease (NAFLD) and liver fibrosis may both progress to cirrhosis and cause liver failure. NAFLD is also a risk factor for cardiovascular disease in the general population, which is also one of the most important causes of morbidity and mortality in lupus patients.8,9 Even though hepatomegaly and hepatosteatosis are frequently observed in abdominal imaging performed for other reasons in SLE patients, the majority of these cases are not evaluated further since the gold standard for diagnosis is liver biopsy, an invasive procedure associated with a number of serious complications.10 Therefore, the prognostic significance of NAFLD and liver fibrosis is still largerly unknown in these patients.

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.

.Several non-invasive diagnostic scores for non-alcoholic fatty liver (NAFL) have been developed one of the most recent scores is HSI score hepatic steatosis index Multivariate analysis indicated that high serum alanine aminotransferase (ALT) to serum aspartate aminotransferase (AST) ratio, high body mass index (BMI), and diabetes mellitus were independent risk factors of NAFLD (all P \< 0.001). Using these variables, a formula was derived by a logistic regression model: hepatic steatosis index (HSI) = 8 × (ALT/AST ratio) + BMI (+2, if female; +2, if diabetes mellitus). HSI had an area under receiver-operating curve of 0.812 (95% confidence interval, 0.801-0.824). At values of \<30.0 or \>36.0, HSI ruled out NAFLD with a sensitivity of 93.1%, or detected NAFLD with a specificity of 92.4%, respectively. Of 2692 subjects with HSI \<30.0 or \>36.0 in the derivation cohort, 2305 (85.6%) were correctly classified. HSI was validated in the subsequent validation cohort.

HSI is a simple, efficient screening tool for NAFLD that may be utilized for selecting individuals for liver ultrasonography and for determining the need for lifestyle modifications.12

Being tested
Fibroscan
Keywords
NAFLD and SLE
Medical subject headings
Non-alcoholic Fatty Liver Disease, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibroscanDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 .

    Measured: baseline

Secondary outcomes (1)
  1. determinate risk factors in SLE patients contributing to NAFLD and liver fibrosis

    We will determine the risk factor in SLE patients we take and determine the risk factors in patients detected as having NAFLD and determine the risk factors may contributed to develop NAFLD

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completionOct 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601361
Sponsor's protocol ID
NAFLD in SLE
Acronym
NAFLD and SLE
Status last verified
Sep 2024
First submitted
7 Sep 2024
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35403493

Questions about this trial

What is this clinical trial studying?

An observational study of NAFLD - Nonalcoholic Fatty Liver Disease, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ayman Makram Ayad, physician (+20 01070387266, Aimen.16266102@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

estimation of prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601361, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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