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Clinical Trials/NCT03602573
NCT03602573
Unknown
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country200 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nonalcoholic Steatohepatitis
Sponsor
Chang Gung Memorial Hospital
Enrollment
200
Locations
1
Primary Endpoint
The impact of estrogen level on liver steatosis by FibroScan touch 520
Last Updated
7 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
July 31, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yi-Cheng Chen

Associate professor

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • Females, age of 46-55 years
  • Willing and able to comply with the study requirements
  • Willing and able to provide written informed consent to participate in the study

Exclusion Criteria

  • Unable to complete the noninvasive procedure of VCET and CAP
  • Unwilling to provide written informed consent to participate in the study

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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