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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

October 31, 2012
July 17, 2013
May 2013
October 2013   (final data collection date for primary outcome measure)
Liver fat content(%) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
MRS (magnetic resonance spectroscopy analysis): liver fat content (%).
Same as current
Complete list of historical versions of study NCT01720719 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
  • Anthropometrics [ 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)
Not Provided
Not Provided
 
Atorvastatin Versus Vitamin E in Treatment of Non-alcoholic Fatty Liver Disease
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fatty Liver
  • Dyslipidemias
  • Diabetes Mellitus
  • Drug: atorvastatin
    Oral atorvastatin 20mg, qd, for 24 weeks
  • Drug: Vitamin E
    Oral Vitamin E 300mg, qd, for 24 weeks
  • Active Comparator: Vitamin E
    Oral Vitamin E 300mg, qd, for 24 weeks
    Intervention: Drug: Vitamin E
  • Experimental: Atorvastatin
    Oral atorvastatin 20mg, qd, for 24 weeks
    Intervention: Drug: atorvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
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
China
 
NCT01720719
WS2334187
Yes
Xin Gao, Fudan University
Xin Gao
Pfizer
Principal Investigator: Xin Gao, doctor Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
Fudan University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP