Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nonalcoholic Steatohepatitis
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The impact of estrogen level on liver steatosis by FibroScan touch 520
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Investigators
Yi-Cheng Chen
Associate professor
Chang Gung Memorial Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
The impact of estrogen level on liver steatosis by FibroScan touch 520
Time Frame: 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
Time Frame: 1 year
The association of estrogen level with the severity of liver fibrosis.