Hepatic Steatosis, Menopause, Non Alcholic Fatty Liver Disease
Conditions
Keywords
Menopausal hormone therapy, Non-alcoholic fatty liver disease, Liver function, Attenuation imaging, Hepatic steatosis, Postmenopausal women
Brief summary
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.
Detailed description
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.
Interventions
Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications.
Sponsors
Ipek B. Ozcivit Erkan, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female participants aged 40 years or older * Postmenopausal status (defined as ≥12 months of amenorrhea) * No prior use of menopausal hormone therapy in the last 6 months * Willingness to participate and provide informed consent
Exclusion criteria
* History of liver disease, liver malignancy, or liver transplantation * Current or past alcohol consumption exceeding 20g/day * Premature ovarian failure * History of any active malignancy * Use of medications known to affect liver enzymes or fat metabolism * Current participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ATI (Attenuation Imaging) value from baseline to 6 months | Baseline and 6 months | Quantitative measurement of hepatic steatosis using ultrasound-based attenuation imaging (ATI). A decrease in ATI indicates improvement in hepatic fat content. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FIB-4 Score from baseline to 6 months | Baseline and 6 months | Assessment of liver fibrosis using FIB-4 score formula: \[Age × AST\] / \[Platelet × √ALT\]. Lower scores indicate less fibrosis. |
| Change in Liver Enzyme Levels (AST, ALT, GGT, LDH) | Baseline and 6 months | Serum levels of AST, ALT, GGT, and LDH measured through standard laboratory assays to evaluate liver function. |
| Change in Lipid Profile (LDL, Total Cholesterol) | Baseline and 6 months | Evaluation of lipid metabolism via total cholesterol and LDL levels to assess metabolic effects of MHT. |
Countries
Turkey (Türkiye)
Outcome results
None listed