Liver Fibrosis in Peri-menopausal Women

Status Recruiting

Clinical Trial 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:

1. Females, age of 46-55 years

2. Willing and able to comply with the study requirements

3. Willing and able to provide written informed consent to participate in the study

Exclusion criteria:

1. Unable to complete the noninvasive procedure of VCET and CAP

2. Unwilling to provide written informed consent to participate in the study

Laboratory tests and examinations:

Baseline and two follow-up visits (every 6 months):

1. Blood pressure

2. BW, BH, waist circumference, BMI

3. Complete blood cell (CBC) count

4. Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP

5. Sugar (fasting), HbA1c, insulin, HOMA-IR

6. DM lipid profiles, adiponectin, leptin

7. Liver ultrasound, FibroScan touch 520

8. FSH, Estrodiol (E2), LH

9. TSH, free T4

10. HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive)

11. ANA, Anti-mitochondrial antibody

12. Review history of drug and menstruation cycles

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03602573
Study type	Observational
Source	Chang Gung Memorial Hospital
Contact	Yi-Cheng Chen, MD
Phone	886-3-3281200
Email	yichengliver@gmail.com
Status	Recruiting
Phase
Start date	August 1, 2018
Completion date	July 31, 2019

View Details

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