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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01720719
• Other study ID #: WS2334187
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2012
• Last updated: February 2, 2016
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: Xin Gao, doctor
• Phone: 862164041990
• Email: gao.xin[@]zs-hospital.sh.cn; happy20061208[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemias
• Fatty Liver
• Liver Diseases

Intervention

Drug:
• atorvastatin
Oral atorvastatin 20mg, qd, for 24 weeks
• Vitamin E
Oral Vitamin E 300mg, qd, for 24 weeks

Locations

Country	Name	City	State
China	Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xin Gao	Pfizer

Country where clinical trial is conducted

China, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat content(%)	MRS (magnetic resonance spectroscopy analysis): liver fat content (%).	24 weeks	No
Secondary	Abdominal visceral fat area(cm2)	MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)	24 weeks	No
Secondary	Abdominal subcutaneous fat area(cm2)	MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)	24 weeks	No
Secondary	Lipid profiles	lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)	24 weeks	No
Secondary	Liver enzymes	liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))	24 weeks	Yes
Secondary	Glucose metabolism	fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide	24 weeks	No
Secondary	Body weight	Body weight	24 weeks	No
Secondary	Anthropometric test	waist and hip circumferences	24 weeks	No
Secondary	Muscle enzymes	MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)	24 weeks	Yes