Non-Alcoholic Fatty Liver Disease (NAFLD)
Conditions
Interventions
Levocarnitine at a 600mg thrice daily for 6months
control
Sponsors
Kanazawa University Graduate School of Medical Science, Disease Contral and Homeostasis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who are 1. Diagnosed as NAFLD by histological examination. 2. Tolerable to take Levocarnicine for 6 month. 3. Child-Pugh classification A. 4. Age order than or equal to 20years old and younger than 80 yaers old at time of the consent. 5. Performance status(ECOG scale) 0 or 1. 6. The function of main organs should should be well maintained within 14 days before time of the consent. 6-1, WBC;greater than or equal to 3,000 and less than 12,000/uL 6-2, Hb;greater than or equal to 9.0g/dL 6-3, Platelet;greater than or equal to 70,000/uL 6-4, Total Bilirubin;less than or equal to 1.5mg/dL or lower than upper limit of the facility 6-5, Serum ALT;greater than upper limit of the facility and less than or equal to 300 U/L 6-6, Serum Cr;less than or equal to 1.2mg/dL or lower than upper limit of the facility 6-7, The patients have to agree to join this study by their free wills
Exclusion criteria
Exclusion criteria: The following patients should be excluded 1. Infected with HBV or HCV 2. Alcohol assumption per day; greater than 20g 3. Complicated with malignant disease including hepatocellular carcinoma 4. Complicated with obvious hepatic encephalopathy 5. Complicated with active infectious disease 6. Complicated with Critical complications 7. Nursing and Pregnant woman 8. Taking contraindicating medicines with Levocarnitine 9. Taking pioglitazone and metformin 10.the other patients who the doctors in charge consider should not enter this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of serum ALT after taking Levocarnitine for 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following items are assessed after taking Levocarnitine for 6 months 1. Safety 2. Improvement of metabolic disorder 3. Improvement of histological findings of the liver 4. the effect of Levocarnitine on the gene expression(mRNA) 5. The effect of Levocarnitine on immunoreaction in the liver 6. The concentration of the Levocarnitine and the effect of Levocarnitine on fatty acid composition in the liver | — |
Countries
Japan
Contacts
Public ContactTatsuya Yamashita
kanazawa University Hospital Department of Gastroenterology
Outcome results
None listed