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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Fudan University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Xin Gao, Fudan University
ClinicalTrials.gov Identifier:
NCT01720719
First received: October 31, 2012
Last updated: July 17, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Fatty Liver
Dyslipidemias
Diabetes Mellitus
Drug: atorvastatin
Drug: Vitamin E
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Liver fat content(%) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    MRS (magnetic resonance spectroscopy analysis): liver fat content (%).


Secondary Outcome Measures:
  • Abdominal visceral fat area(cm2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)

  • Abdominal subcutaneous fat area(cm2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)

  • Lipid profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)

  • Liver enzymes [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))

  • Glucose metabolism [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide

  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Body weight

  • Anthropometric test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    waist and hip circumferences

  • Muscle enzymes [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)


Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720719

Contacts
Contact: Xin Gao, doctor 862164041990 ext 8021 gao.xin@zs-hospital.sh.cn; happy20061208@126.com
Contact: Hongmei Yan, doctor 13761666976 yan.hongmei@zs-hospital.sh.cn

Locations
China, Shanghai
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xin Gao, doctor    862164041990 ext 8021    gao.xin@zs-hospital.sh.cn   
Contact: Hongmei Yan, doctor    13761666976    yan.hongmei@zs-hospital.sh.cn   
Principal Investigator: Xin Gao, doctor         
Sub-Investigator: hongmei Yan, doctor         
Sub-Investigator: Mingfeng Xia, doctor         
Sponsors and Collaborators
Xin Gao
Pfizer
Investigators
Principal Investigator: Xin Gao, doctor Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
  More Information

Publications:

Responsible Party: Xin Gao, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01720719     History of Changes
Other Study ID Numbers: WS2334187
Study First Received: October 31, 2012
Last Updated: July 17, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Non-alcoholic Fatty Liver Disease
Dyslipidemias
Diabetes Mellitus
atorvastatin
Vitamin E

Additional relevant MeSH terms:
Diabetes Mellitus
Dyslipidemias
Fatty Liver
Liver Diseases
Digestive System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Alpha-Tocopherol
Atorvastatin
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Anticholesteremic Agents
Antimetabolites
Antioxidants
Enzyme Inhibitors
Growth Substances
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014