The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C and non-alcoholic fatty liver disease.
Previous studies have preliminary proven the safety and efficacy of atorvastatin tablets in the treatment of Non-alcoholic fatty liver disease (NAFLD).However, the sample size of these studies is small and most studies use B-ultrasound or CT for semi-quantitative determination of liver fat content. The defects of evaluation methods seriously affect the accuracy of the studies. Also, antioxidant agents have been proposed as a potentially effective treatment. Vitamin E is a potent antioxidant compound, which has been tested in pediatric NAFLD because of the absence of side effects. Conflicting results have been reported in clinical trials, both in children and in adults. The project intends to adopt advanced proton magnetic resonance spectroscopy (1H-MRS) to non-invasively and precisely determine liver fat content and understand the change in liver fat content before and after the treatment with atorvastatin tablets or Vitamin E in NAFLD patients with abnormal lipid metabolism and type 2 diabetes. We also intend to compare the therapeutic effects of atorvastatin and Vitamin E in the treatment of NAFLD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Oral atorvastatin 20mg, qd, for 24 weeks
Oral Vitamin E 300mg, qd, for 24 weeks
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGLiver fat content(%)
MRS (magnetic resonance spectroscopy analysis): liver fat content (%).
Time frame: 24 weeks
Abdominal visceral fat area(cm2)
MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)
Time frame: 24 weeks
Abdominal subcutaneous fat area(cm2)
MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)
Time frame: 24 weeks
Lipid profiles
lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)
Time frame: 24 weeks
Liver enzymes
liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))
Time frame: 24 weeks
Glucose metabolism
fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide
Time frame: 24 weeks
Body weight
Body weight
Time frame: 24 weeks
Anthropometric test
waist and hip circumferences
Time frame: 24 weeks
Muscle enzymes
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MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)
Time frame: 24 weeks