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NCT03602573 Clinical Trial

Liver Fibrosis in Peri-menopausal Women

Menopause Clinical Trial

Official title:
Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03602573
Other study ID # LSM-PMW
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date July 31, 2019

Study information
Verified date August 2018
Source Chang Gung Memorial Hospital
Contact Yi-Cheng Chen, MD
Phone 886-3-3281200
Email yichengliver@gmail.com
Is FDA regulated No
Health authority
Study type Observational

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 46 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The impact of estrogen level on liver steatosis by FibroScan touch 520 The association of estrogen level with the severity of liver steatosis. 1 year
Primary The impact of estrogen level on liver fibrosis by FibroScan touch 520 The association of estrogen level with the severity of liver fibrosis. 1 year
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