Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The impact of estrogen level on liver steatosis by FibroScan touch 520
研究概览
简要总结
This is a prospective observational study in a single medical center.
The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers.
Recruitment period: 2018/08/01 to 2019/07/31
Patient number: 200 females
Inclusion criteria:
- Females, age of 46-55 years
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
- Unable to complete the noninvasive procedure of VCET and CAP
- Unwilling to provide written informed consent to participate in the study
Laboratory tests and examinations:
Baseline and two follow-up visits (every 6 months):
- Blood pressure
- BW, BH, waist circumference, BMI
- Complete blood cell (CBC) count
- Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP
- Sugar (fasting), HbA1c, insulin, HOMA-IR
- DM lipid profiles, adiponectin, leptin
- Liver ultrasound, FibroScan touch 520
- FSH, Estrodiol (E2), LH
- TSH, free T4
- HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive)
- ANA, Anti-mitochondrial antibody
- Review history of drug and menstruation cycles
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 46 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, age of 46-55 years
- •Willing and able to comply with the study requirements
- •Willing and able to provide written informed consent to participate in the study
排除标准
- •Unable to complete the noninvasive procedure of VCET and CAP
- •Unwilling to provide written informed consent to participate in the study
结局指标
主要结局
The impact of estrogen level on liver steatosis by FibroScan touch 520
时间窗: 1 year
The association of estrogen level with the severity of liver steatosis.
The impact of estrogen level on liver fibrosis by FibroScan touch 520
时间窗: 1 year
The association of estrogen level with the severity of liver fibrosis.
次要结局
未报告次要终点
研究者
Yi-Cheng Chen
Associate professor
Chang Gung Memorial Hospital
