Establishment of Non-Alcoholic Fatty Liver Disease Cohort for prevention and management of Cardio-cerebrovascular Disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007762
- Lead Sponsor
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
1) Patients 19 years old and older
2) Patients with NAFLD
: patients who are suspected of having fatty liver with intrahepatic fat deposition on an imaging test or liver biopsy performed within 3 months.
3) Patients who consented to participate the study and signed a written informed consent
1) Patients with significant alcohol intake of the following within 2 years prior to baseline (140 g or more per week for female, 210 g or more per week for male; types of drinks equivalent to 10 g of alcohol: 360 mL of beer, 120 mL of wine, 45 mL of whiskey)
2) Type 1 diabetes (insulin-dependent diabetes mellitus)
3) Patients with hepatobiliary disease that may show abnormal liver function without NAFLD (e.g., viral hepatitis such as HBV or HCV, drug-induced liver injury, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, etc.)
4) Patients with malignant tumors including liver cancer. But among them, patients with no recurrence within 5 years after the last treatment can be included.
5) Patients who have taken drugs that could cause fatty liver disease within 8 weeks from the baseline. (e.g., amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids (prednisone 10 mg or more per day), anabolic steroids, estrogen over the usual dose of hormone replacement therapy, valproate, etc.)
6) Patients who the investigators consider not suitable to participate in this study for the following reasons: severe renal impairment, severe lung disease, severe cardiovascular disease, severe neurological or psychiatric disease, muscular disease, etc.
7) Patients with a history of immune diseases such as inflammatory bowel disease, autoimmune thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis, etc.
8) Patients who are positive for anti-HIV antibody
9) Patients who are not suitable to be included in the study by the judgment of the investigators
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of cardiocerebrovascular disease such as myocardial infarction and stroke
- Secondary Outcome Measures
Name Time Method Development of hypertension;Development of diabetes;Development of liver cirrhosis;Development of hepatocellular carcinoma;Development of the following cirrhosis-related complications : variceal bleeding, clinically evident ascites, hepatic encephalopathy, model of end stage liver disease (MELD) >14, hepatic venous pressure gradient (HVPG) >10 mmHg);Liver transplantation;Development of chronic kidney disease defined as proteinuria (=1+ on dipstick test) or GFR<60ml/min on two or more tests;Decreased renal function defined as the Cr increase of 50% or more, GFR decrease of 30% or more, or GFR <45 ml/min;Development of extrahepatic cancer;Quality of Life on Liver Disease Specific Quality of Life Tool (LDQLL) Survey;Survey results on nutrition and dietary Status;Survey results on exercise ;Survey results on drinking;Thyroid function test;Sarcopenia