Liver Fibrosis in Peri-menopausal Women

• Conditions: Liver Fibroses; Nonalcoholic Steatohepatitis; Menopause

• Registration Number: NCT03602573
• Lead Sponsor: Chang Gung Memorial Hospital

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:

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Status Verified: 2018-08
• Study Start: 2018-08-01
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of estrogen level on liver steatosis by FibroScan touch 520	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	1 year	The association of estrogen level with the severity of liver fibrosis.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan