The evalustion of fatty liver disease and post-surgical response in patients undergoing bariatric surgery
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003527
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
Subjects who understood this clinical study and provided written informed consent to join the study by his or her own decision
- Aged 19 or more years or less than 60 years
- Subjects who have body mass index =30 kg per square meter and metabolic disease (at least one the following: impaired fasting glucose, hemoglobin A1c 5.7% or more, diabetes, nonalcoholic fatty liver disease, hypertension, hypertriglyceridemia, or metabolic syndrome).
- Absence of specific congenital diseases or absence of other chronic diseases and their symptom or signs requiring specific treatment, except for metabolic diseases
- Aged less than 19 years or 60 years or more
- Pregnant or lactating women
- Body weight >159 kg
- Drug abusers
- Alcohol consumption (alcohol intake >20 g/day for women; >30 g/day for men) during = 3months in the past 5 years
- Psychiatric patients on medical care or medication or subjects with bulimia
- Those with AST or ALT level higher than 5 times the upper limit of normal
- Those with platelet count < 60,000 per microliter or with prothrombin time longer than 4 seconds or more than the upper limit of normal (14 seconds)
- Contraindications to MRI examination
- Other specific 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) within a year
- Other systemic diseases seemed to be inappropriate for study participation
- Subjects with HIV infection
- Subjects with ischemic heart diseases
- Subjects with estimated glomerular filtration rates < 45 ml/min/1.73 square meters
- Subjects with clinical or subclinical hyperthyroidism or hypothyroidism
- Inappropriate for study participation at the discretion of attending physicians
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of liver stiffness measurement (LSM) values measured by MRI before and after bariatric surgery
- Secondary Outcome Measures
Name Time Method Change of liver fat content measured by MRI and of body weight before and after bariatric surgery;Relationsip between fibrosis grade (0-4) at biopsy during bariatric suregery and MRI-measured LSM change after surgery;Evaluation of determinant for weight loss and the improvement of NAFLD after weight loss