Effects of Menopausal Hormone Therapy on Liver Function and Non-Alcoholic Fatty Liver Disease: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in ATI (Attenuation Imaging) value from baseline to 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1: MHT Group
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.
干预措施: Menopausal hormone therapy (Drug)
Group 2: Control Group
Postmenopausal women not receiving MHT. Monitored without treatment and evaluated using the same laboratory and imaging parameters.
结局指标
主要结局
Change in ATI (Attenuation Imaging) value from baseline to 6 months
时间窗: 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.
次要结局
- Change in FIB-4 Score from baseline to 6 months(Baseline and 6 months)
- Change in Liver Enzyme Levels (AST, ALT, GGT, LDH)(Baseline and 6 months)
- Change in Lipid Profile (LDL, Total Cholesterol)(Baseline and 6 months)
研究者
Ipek B. Ozcivit Erkan, MD
Obstetrician and Gynecologist
Istanbul University - Cerrahpasa