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

The clinical performance of imaging and biomarker assessments for non-alcoholic fatty liver disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0003144
Enrollment
75
Registered
2018-08-29
Start date
2017-11-25
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Gachon University Gil Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Korea, Republic of

Contacts

Public ContactDAE HO LEE

Gachon University Gil Medical Center

drhormone@naver.com+82-32-458-2733

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026