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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xin Gao
• Collaborator: Pfizer
• Treatments: alpha-Tocopherol; Atorvastatin; Atorvastatin Calcium; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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.