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Liver Fibrosis in Peri-menopausal Women

NCT03602573 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-08-21

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yi-Cheng Chen, MD · Chang Gung Memorial Hospital

Eligibility

Min Age
46 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602573 on ClinicalTrials.gov