MRI-based evaluation of non-alcoholic fatty liver disease
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005161
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Korean males aged 20 to under 40 at the time of screening
Those who are over 50 kg and have a body mass index (kg per meter squared) of 18.5 or more and less than 28
No congenital or chronic disease requiring treatment and no medical condition or findings as a result of medical examination
A person who is determined to be suitable as a clinical test subject as a result of laboratory tests, such as a questionnaire and physical examination, serum test, hematology test, blood chemistry test and urine test
A person who, after hearing and fully understanding the details of this clinical trial, voluntarily decided to participate and agrees in writing to follow the precautions
Those whose AST and ALT exceed 2 times the upper limit of the normal range
A person who is unable to handle the noise or isolation environment in the test equipment at the MRI laboratory or contraindicated for MRI examination
Subjects diagnosed with alcoholic liver disease
Other identified liver diseases: hepatitis B or C, autoimmune hepatitis, drug-induced liver damage, other liver diseases.
Subjects with cirrhosis or biliary tract disease
A history of taking medications that cause secondary fatty liver within the last year
(corticosteroids, tamoxifen, amiodarone, methotrexate, etc.),
Patients with diabetes
Complications of diabetes/hypertension/other metabolic diseases or related diseases (ischemic heart disease, heart failure, chronic kidney disease stage =3)
Persons deemed unsuitable due to other severe systemic diseases
HIV-infected patients
Pregnant women
Drink more than 3 cups (approximately 30 g) daily within the last 10 years or drink more than 1 cup (approximately 10 g) daily within the last 1 year
patients with overt proteinuria
Patients with hypersensitivity or hypothyroidism/hypothyroidism
A person who is determined to be unsuitable to participate in a clinical trial according to the judgment of the chief investigator and attending physician
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI-proton-density fat fraction (%), MRE liver stiffness measurement (kPa)
- Secondary Outcome Measures
Name Time Method Transient elastography-measured controlled attenuation parameter(dB/m) and liver stiffness measurement (kPa);correlations between MRI-measured parameters with other clinical parameters