A Phase 4 interventional study of atorvastatin and Vitamin E in Fatty Liver, Dyslipidemias and Diabetes Mellitus, sponsored by Xin Gao. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Xin Gao · Phase 4, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Xin Gao is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral Vitamin E 300mg, qd, for 24 weeks
Drug: Vitamin E
Oral atorvastatin 20mg, qd, for 24 weeks
Drug: atorvastatin
Oral atorvastatin 20mg, qd, for 24 weeks
Oral Vitamin E 300mg, qd, for 24 weeks
Liver 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
MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)
Time frame: 24 weeks
This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Xin Gao