Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-08-01
2019-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pre-menopause
No interventions assigned to this group
post-menopause
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Unwilling to provide written informed consent to participate in the study
46 Years
55 Years
FEMALE
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Yi-Cheng Chen
Associate professor
Principal Investigators
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Yi-Cheng Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LSM-PMW
Identifier Type: -
Identifier Source: org_study_id
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