Atorvastatin Versus Vitamin E in Treatment of Non-alcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720719
Recruitment Status : Unknown
Verified February 2016 by Xin Gao, Fudan University.
Recruitment status was:  Recruiting
First Posted : November 2, 2012
Last Update Posted : February 3, 2016
Information provided by (Responsible Party):
Xin Gao, Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fatty Liver Dyslipidemias Diabetes Mellitus Drug: atorvastatin Drug: Vitamin E Phase 4

Detailed Description:
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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Randomized Open Label Trial on the Impact of 24 Weeks of Atorvastatin Therapy on Liver Fat Content and Abdominal Fat Content in Patients With Type 2 Diabetes Combined With High LDL-C and Non-alcoholic Fatty Liver Disease
Study Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: Vitamin E
Oral Vitamin E 300mg, qd, for 24 weeks
Drug: Vitamin E
Oral Vitamin E 300mg, qd, for 24 weeks

Experimental: Atorvastatin
Oral atorvastatin 20mg, qd, for 24 weeks
Drug: atorvastatin
Oral atorvastatin 20mg, qd, for 24 weeks

Primary Outcome Measures :
  1. Liver fat content(%) [ Time Frame: 24 weeks ]
    MRS (magnetic resonance spectroscopy analysis): liver fat content (%).

Secondary Outcome Measures :
  1. Abdominal visceral fat area(cm2) [ Time Frame: 24 weeks ]
    MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)

  2. Abdominal subcutaneous fat area(cm2) [ Time Frame: 24 weeks ]
    MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)

  3. Lipid profiles [ Time Frame: 24 weeks ]
    lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)

  4. Liver enzymes [ Time Frame: 24 weeks ]
    liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))

  5. Glucose metabolism [ Time Frame: 24 weeks ]
    fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide

  6. Body weight [ Time Frame: 24 weeks ]
    Body weight

  7. Anthropometric test [ Time Frame: 24 weeks ]
    waist and hip circumferences

  8. Muscle enzymes [ Time Frame: 24 weeks ]
    MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Sign informed consent before involvement in any trial-related activity (trial-related activity refers to measures that will not be adopted during the normal treatment of patients).
  2. Male or female, 18 years ≤ age ≤ 70 years.
  3. Type 2 diabetes (already diagnosed or oral glucose tolerance test(OGTT) tested and found complying with the 2003 ADA diagnostic criteria for diabetes).
  4. Patients with non-alcoholic fatty liver disease, MRS measurement of liver fat content> 10%.
  5. Without taking any lipid-lowering drugs or Vitamin E in 3 months before enrollment.
  6. LDL-C ≥ 2.6mmol/L.
  7. No heavy drinking history (alcohol intake: male < 20g/d, female < 10g/d).
  8. HBsAg (-), HCV-Ab (-).
  9. 18.5 kg/m2 ≤ BMI ≤ 40kg/m2

Exclusion Criteria:

  1. Liver, renal dysfunction (ALT or AST is 2.5 times higher than the upper limit of normal, or total bilirubin(TB) is 1.5 times higher than the upper limit of normal, or Cr ≥ 115μmol/L).
  2. Muscle enzyme is 2 times higher than normal.
  3. Type 1 diabetes, gestational diabetes, or other special types of diabetes.
  4. Has not used drugs that may affect the liver fat content, such as glucocorticoids and thyroxine within one month before and during the trial.
  5. With hypothyroidism, hypothalamic-pituitary dysfunction, sleep apnea syndrome, acanthosis nigricans, polycystic ovary syndrome, psoriasis, colorectal adenomas polyps and other diseases that NAFLD is easily associated with.
  6. Previous history of chronic viral hepatitis, autoimmune liver disease, drug-induced liver disease and other liver diseases caused by genetic factors.
  7. Severe uncontrolled hypertension (treated, sitting resting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100mmHg).
  8. Pregnancy, breastfeeding, planned pregnancy, or failure to take adequate contraceptive measures (contraception measures include sterilization, intrauterine device(IUD), oral contraceptives and consistent condom use).
  9. With intellectual, psychological or language barriers, so that the subjects cannot fully understand or cooperate with the study.
  10. Any circumstances that may affect the implementation or results of the study.
  11. Class III or Class IV heart disease by New York Heart Association(NYHA) classification, unstable angina or attack of myocardial infarction in recent 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720719

Contact: Xin Gao, doctor 862164041990 ext 8021;
Contact: Hongmei Yan, doctor 13761666976

China, Shanghai
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xin Gao, doctor    862164041990 ext 8021   
Contact: Hongmei Yan, doctor    13761666976   
Principal Investigator: Xin Gao, doctor         
Sub-Investigator: hongmei Yan, doctor         
Sub-Investigator: Mingfeng Xia, doctor         
Sponsors and Collaborators
Xin Gao
Principal Investigator: Xin Gao, doctor Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University


Responsible Party: Xin Gao, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University Identifier: NCT01720719     History of Changes
Other Study ID Numbers: WS2334187
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016

Keywords provided by Xin Gao, Fudan University:
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Vitamin E

Additional relevant MeSH terms:
Diabetes Mellitus
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Lipid Metabolism Disorders
Vitamin E
Atorvastatin Calcium
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Protective Agents