Liver Fibrosis in Peri-menopausal Women

August 20, 2018 updated by: Yi-Cheng Chen, Chang Gung Memorial Hospital

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung memorial hospital
        • Contact:
        • Sub-Investigator:
          • Rong-Nan Chien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Females, age of 46-55 years, premenopause and postmenopause

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
pre-menopause
post-menopause

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of estrogen level on liver steatosis by FibroScan touch 520
Time Frame: 1 year
The association of estrogen level with the severity of liver steatosis.
1 year
The impact of estrogen level on liver fibrosis by FibroScan touch 520
Time Frame: 1 year
The association of estrogen level with the severity of liver fibrosis.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yi-Cheng Chen, MD, Chang Gung memorial hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSM-PMW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menopause

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe