Liver Fibrosis in Peri-menopausal Women

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03602573

Enrollment

200

Registered

2018-07-27

Start date

2018-08-01

Completion date

2019-07-31

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibroses, Menopause, Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic steatohepatitis, Liver fibrosis, Menopause, Hormone

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

46 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Taiwan

Contacts

Primary ContactYi-Cheng Chen, MD

yichengliver@gmail.com886-3-3281200

Outcome results