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

February 2, 2016 updated by: Xin Gao

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xin Gao, doctor
        • Sub-Investigator:
          • hongmei Yan, doctor
        • Sub-Investigator:
          • Mingfeng Xia, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver fat content(%)
Time Frame: 24 weeks
MRS (magnetic resonance spectroscopy analysis): liver fat content (%).
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal visceral fat area(cm2)
Time Frame: 24 weeks
MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)
24 weeks
Abdominal subcutaneous fat area(cm2)
Time Frame: 24 weeks
MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)
24 weeks
Lipid profiles
Time Frame: 24 weeks
lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)
24 weeks
Liver enzymes
Time Frame: 24 weeks
liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))
24 weeks
Glucose metabolism
Time Frame: 24 weeks
fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide
24 weeks
Body weight
Time Frame: 24 weeks
Body weight
24 weeks
Anthropometric test
Time Frame: 24 weeks
waist and hip circumferences
24 weeks
Muscle enzymes
Time Frame: 24 weeks
MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xin Gao

Collaborators

Pfizer

Investigators

  • Principal Investigator: Xin Gao, doctor, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 1, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS2334187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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