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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MHT Group | Active Comparator | Postmenopausal women receiving menopausal hormone therapy (oral or transdermal estrogen). Evaluated at baseline and after 6 months for liver function, lipid profile, FIB-4 score, and attenuation imaging. |
|
| Group 2: Control Group | No Intervention | Postmenopausal women not receiving MHT. Monitored without treatment and evaluated using the same laboratory and imaging parameters. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menopausal hormone therapy | Drug | Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Change in Liver Enzyme Levels (AST, ALT, GGT, LDH) |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal women aged 40 years and older were eligible for inclusion. Only biologically female participants were considered, as the study focused on the effects of estrogen deficiency and menopausal hormone therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine | Istanbul | Beyoğlu | Turkey (Türkiye) |
De-identified individual data will be made available upon reasonable request from the corresponding author for academic and non-commercial use.
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Serum levels of AST, ALT, GGT, and LDH measured through standard laboratory assays to evaluate liver function. |
| 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. | Baseline and 6 months |