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

Primary Purpose

Fatty Liver, Dyslipidemias, Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

atorvastatin

Vitamin E

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Non-alcoholic Fatty Liver Disease, Dyslipidemias, Diabetes Mellitus, atorvastatin, Vitamin E

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Male or female, 18 years ≤ age ≤ 70 years.
Type 2 diabetes (already diagnosed or oral glucose tolerance test(OGTT) tested and found complying with the 2003 ADA diagnostic criteria for diabetes).
Patients with non-alcoholic fatty liver disease, MRS measurement of liver fat content> 10%.
Without taking any lipid-lowering drugs or Vitamin E in 3 months before enrollment.
LDL-C ≥ 2.6mmol/L.
No heavy drinking history (alcohol intake: male < 20g/d, female < 10g/d).
HBsAg (-), HCV-Ab (-).
18.5 kg/m2 ≤ BMI ≤ 40kg/m2

Exclusion Criteria:

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).
Muscle enzyme is 2 times higher than normal.
Type 1 diabetes, gestational diabetes, or other special types of diabetes.
Has not used drugs that may affect the liver fat content, such as glucocorticoids and thyroxine within one month before and during the trial.
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.
Previous history of chronic viral hepatitis, autoimmune liver disease, drug-induced liver disease and other liver diseases caused by genetic factors.
Severe uncontrolled hypertension (treated, sitting resting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100mmHg).
Pregnancy, breastfeeding, planned pregnancy, or failure to take adequate contraceptive measures (contraception measures include sterilization, intrauterine device(IUD), oral contraceptives and consistent condom use).
With intellectual, psychological or language barriers, so that the subjects cannot fully understand or cooperate with the study.
Any circumstances that may affect the implementation or results of the study.
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.

Sites / Locations

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vitamin E

Atorvastatin

Arm Description

Oral Vitamin E 300mg, qd, for 24 weeks

Oral atorvastatin 20mg, qd, for 24 weeks

Outcomes

Primary Outcome Measures

Liver fat content(%)

MRS (magnetic resonance spectroscopy analysis): liver fat content (%).

Secondary Outcome Measures

Abdominal visceral fat area(cm2)

MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)

Abdominal subcutaneous fat area(cm2)

MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)

Lipid profiles

lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)

Liver enzymes

liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))

Glucose metabolism

fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide

Body weight

Anthropometric test

waist and hip circumferences

Muscle enzymes

MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)

Full Information

NCT ID

NCT01720719

First Posted

October 31, 2012

Last Updated

February 2, 2016

Sponsor

Xin Gao

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01720719

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xin Gao

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver, Dyslipidemias, Diabetes Mellitus

Keywords

Non-alcoholic Fatty Liver Disease, Dyslipidemias, Diabetes Mellitus, atorvastatin, Vitamin E

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin E

Arm Type

Active Comparator

Arm Description

Oral Vitamin E 300mg, qd, for 24 weeks

Arm Title

Atorvastatin

Arm Type

Experimental

Arm Description

Oral atorvastatin 20mg, qd, for 24 weeks

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Intervention Description

Oral atorvastatin 20mg, qd, for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Vitamin E

Intervention Description

Oral Vitamin E 300mg, qd, for 24 weeks

Primary Outcome Measure Information:

Title

Liver fat content(%)

Description

MRS (magnetic resonance spectroscopy analysis): liver fat content (%).

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Abdominal visceral fat area(cm2)

Description

MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)

Time Frame

24 weeks

Title

Abdominal subcutaneous fat area(cm2)

Description

MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)

Time Frame

24 weeks

Title

Lipid profiles

Description

lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)

Time Frame

24 weeks

Title

Liver enzymes

Description

liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))

Time Frame

24 weeks

Title

Glucose metabolism

Description

fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide

Time Frame

24 weeks

Title

Body weight

Description

Body weight

Time Frame

24 weeks

Title

Anthropometric test

Description

waist and hip circumferences

Time Frame

24 weeks

Title

Muscle enzymes

Description

MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Male or female, 18 years ≤ age ≤ 70 years. Type 2 diabetes (already diagnosed or oral glucose tolerance test(OGTT) tested and found complying with the 2003 ADA diagnostic criteria for diabetes). Patients with non-alcoholic fatty liver disease, MRS measurement of liver fat content> 10%. Without taking any lipid-lowering drugs or Vitamin E in 3 months before enrollment. LDL-C ≥ 2.6mmol/L. No heavy drinking history (alcohol intake: male < 20g/d, female < 10g/d). HBsAg (-), HCV-Ab (-). 18.5 kg/m2 ≤ BMI ≤ 40kg/m2 Exclusion Criteria: 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). Muscle enzyme is 2 times higher than normal. Type 1 diabetes, gestational diabetes, or other special types of diabetes. Has not used drugs that may affect the liver fat content, such as glucocorticoids and thyroxine within one month before and during the trial. 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. Previous history of chronic viral hepatitis, autoimmune liver disease, drug-induced liver disease and other liver diseases caused by genetic factors. Severe uncontrolled hypertension (treated, sitting resting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100mmHg). Pregnancy, breastfeeding, planned pregnancy, or failure to take adequate contraceptive measures (contraception measures include sterilization, intrauterine device(IUD), oral contraceptives and consistent condom use). With intellectual, psychological or language barriers, so that the subjects cannot fully understand or cooperate with the study. Any circumstances that may affect the implementation or results of the study. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Gao, doctor

Phone

862164041990

Ext

8021

gao.xin@zs-hospital.sh.cn; happy20061208@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hongmei Yan, doctor

Phone

13761666976

yan.hongmei@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xin Gao, doctor

Organizational Affiliation

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Gao, doctor

Phone

862164041990

Ext

8021

gao.xin@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Hongmei Yan, doctor

Phone

13761666976

yan.hongmei@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Xin Gao, doctor

First Name & Middle Initial & Last Name & Degree

hongmei Yan, doctor

First Name & Middle Initial & Last Name & Degree

Mingfeng Xia, doctor

12. IPD Sharing Statement

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

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