Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03602573
Status:
UNKNOWN
Last Update Posted:
2018-08-21
First Post:
2018-07-19
Brief Title:
Liver Fibrosis in Peri-menopausal Women
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20180801 to 20190731
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
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 20180801 to 20190731
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None