This prospective study aims to evaluate the effects of menopausal hormone therapy (MHT) on liver function, lipid profiles, and hepatic steatosis in postmenopausal women. A total of 44 participants will be divided into two groups: 22 received MHT and 22 were monitored without treatment. Biochemical parameters, FIB-4 scores, and attenuation imaging (ATI) measurements are assessed at baseline and after six months. The study investigates whether MHT is associated with favorable changes in liver enzymes, hepatic fat accumulation, and noninvasive fibrosis markers.
This prospective, controlled cohort study is designed to evaluate the effects of menopausal hormone therapy (MHT) on liver function and non-alcoholic fatty liver disease (NAFLD) in postmenopausal women. A total of 44 participants are included and divided into two groups: 22 women will receive MHT and 22 will be monitored without treatment due to the absence of menopausal symptoms. Biochemical parameters including liver enzymes and lipid profiles are measured at baseline and after six months. In addition, hepatic steatosis is quantitatively assessed using attenuation imaging (ATI), a novel ultrasound-based technique, and FIB-4 scores are calculated as noninvasive indicators of liver fibrosis. The MHT regimens included both oral and transdermal estrogen, selected based on clinical indications. ATI measurements are performed using standardized protocols by radiologists blinded to clinical data. The primary aim of the study is to investigate whether MHT is associated with favorable changes in hepatic steatosis and liver-related biomarkers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications.
Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Beyoğlu, Turkey (Türkiye)
Change in ATI (Attenuation Imaging) value from baseline to 6 months
Quantitative measurement of hepatic steatosis using ultrasound-based attenuation imaging (ATI). A decrease in ATI indicates improvement in hepatic fat content.
Time frame: Baseline and 6 months
Change in FIB-4 Score from baseline to 6 months
Assessment of liver fibrosis using FIB-4 score formula: \[Age × AST\] / \[Platelet × √ALT\]. Lower scores indicate less fibrosis.
Time frame: Baseline and 6 months
Change in Liver Enzyme Levels (AST, ALT, GGT, LDH)
Serum levels of AST, ALT, GGT, and LDH measured through standard laboratory assays to evaluate liver function.
Time frame: Baseline and 6 months
Change in Lipid Profile (LDL, Total Cholesterol)
Evaluation of lipid metabolism via total cholesterol and LDL levels to assess metabolic effects of MHT.
Time frame: Baseline and 6 months
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