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.
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.
About this study
Aim of the study :-
- to estimate prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients
- 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
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- 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.
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)
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.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLD - Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Makram Ayad Souliman, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Non Alcoholic Fatty Liver Disease and Liver Fibrosis Among Systemic Lupus Erythematosus Patients at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06601361
- Acronym / sponsor ID
- NAFLD and SLE / NAFLD in SLE
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- Keywords
- NAFLD and SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study :-
- to estimate prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients
- to determine risk factors in SLE patients contributing to NAFLD and liver fibrosis
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years old ,Both sex male and female, diagnosed with SLE
Key inclusion criteria (1 listed)
- Adult patients aged 18 years old ,Both sex male and female, diagnosed with SLE
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanFibroscan (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. | Device | – |
Primary outcome
estimation of prevalence of non alcoholic fatty liver disease and liver fibrosis among Systemic lupus erythematosus patients
Time frame: baseline
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 .
1 secondary outcome
determinate risk factors in SLE patients contributing to NAFLD and liver fibrosis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 35403493Yetginoglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.