None listed
Conditions
Interventions
Procedure/Surgery : Bariatric surgery (sleeve gastrectomy): sleeve gastrectomy via laparoscopic approach.
Single study arm to compare clinical and metabolic parameters before and after the surgery
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of liver stiffness measurement (LSM) values measured by MRI before and after bariatric surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactDAE HO LEE
Gachon University Gil Medical Center
Outcome results
None listed