The methods of clinical assessments for non-alcoholic fatty liver disease

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003144
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

.-Subjects who provided written informed consent
-Aged 19-70 years
-those suspected of having NAFLD and belong to one of the followings: who planned to receive liver biopsy or who received liver biopsy for NAFLD within the past 3 months, NAFLD fibrosis score > 0.675, or liver stiffness on FibroScan > 7.5 kPa
-no congenital or systemic illnesses requiring specific treatment except for NAFLD
-Those seemed appropriate for study participation on screening tests involving medical history, physical examinations, blood cell test, serum/plasma biochemistry, and urine analysis
-Healthy adult subjects aged between 19 and 70 years as normal control subjects

Exclusion Criteria

-Aged less than 19 years or more than 70 years
-Pregnancy
-Drug abusers
-Alcohol drink > 30 g/day (about 3 unit/day) in male and > 20 g/day (about 2 unit/day) in female during the last 5 years
-Contraindications to MRI examination
-Other liver diseases except for NAFLD
-Liver cirrhosis with ascites or biliary tract diseases
-Medications causing fatty liver (e.g., corticosteroids, tamoxifen, amiodarone, methotrexate and others)
-Other systemic diseases seemed to be inappropriate for study participation
-Inappropriate for study participation at the discretion of attending physicians

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between the grade of fibrosis on liver biopsy and liver stiffness measurement (LSM) on MR elastography (MRE);Correlation between MRE-LSM and clinical scores of liver fibrosis (e.g., non-alcoholic fatty liver disease fibrosis score and Fibrosis-4)

Secondary Outcome Measures

Name	Time	Method
Correlation between Liver fat content on MRI-proton density fat fraction (MRI-PDFF) and fat content grade on liver biopsy;Correlation between fat content values MRI-PDFF and MRS methods;The cut-off values of MRE-LSM corresponds to fibrosis stage F3 on liver biopsy;Factors correlate well with MRE-LSM values;Comparisons between group with high grade liver fibrosis and group without hepatic fibrosis (epigenetic and genetic profiles and fecal microbiota)