Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601361
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Studying Non Alcoholic Fatty Liver Disease and Liver Fibrosis Among Systemic Lupus Erythematosus Patients At Assiut University Hospital
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Studying Non Alcoholic Fatty Liver Disease and Liver Fibrosis Among Systemic Lupus Erythematosus Patients At Assiut University Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAFLD and SLE
Brief 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
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
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 SLE2 involvement of liver in SLE is rare and mostly presents as asymptomatic hepatomegaly subclinical adiposity andor increased liver enzymes34 Elevated transaminase levels may be observed in 15-55 of the patient population and can be associated with disease activity45 The most common causes are drug-related liver injury 31 lupus-associated hepatitis 29 and fatty liver disease 186 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 hepatotoxicity7 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 patients89 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 complications10 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-up11 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 lt 0001 Using these variables a formula was derived by a logistic regression model hepatic steatosis index HSI 8 ALTAST ratio BMI 2 if female 2 if diabetes mellitus HSI had an area under receiver-operating curve of 0812 95 confidence interval 0801-0824 At values of lt300 or gt360 HSI ruled out NAFLD with a sensitivity of 931 or detected NAFLD with a specificity of 924 respectively Of 2692 subjects with HSI lt300 or gt360 in the derivation cohort 2305 856 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 modifications12
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 patients89 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 complications10 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-up11 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 lt 0001 Using these variables a formula was derived by a logistic regression model hepatic steatosis index HSI 8 ALTAST ratio BMI 2 if female 2 if diabetes mellitus HSI had an area under receiver-operating curve of 0812 95 confidence interval 0801-0824 At values of lt300 or gt360 HSI ruled out NAFLD with a sensitivity of 931 or detected NAFLD with a specificity of 924 respectively Of 2692 subjects with HSI lt300 or gt360 in the derivation cohort 2305 856 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 modifications12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None