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

NCT01720719 | Unknown Phase 4 DMC

• 1 other identifier: WS2334187
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver; Dyslipidemias; Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Liver fat content(%)

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

  24 weeks

Secondary Outcomes (8)

• Abdominal visceral fat area(cm2)

  24 weeks

• Abdominal subcutaneous fat area(cm2)

  24 weeks

• Lipid profiles

  24 weeks

• Liver enzymes

  24 weeks

• Glucose metabolism

  24 weeks

Study Arms (2)

Vitamin E

ACTIVE COMPARATOR

Oral Vitamin E 300mg, qd, for 24 weeks

Drug: Vitamin E

Atorvastatin

EXPERIMENTAL

Oral atorvastatin 20mg, qd, for 24 weeks

Drug: atorvastatin

Interventions

atorvastatin DRUG

Oral atorvastatin 20mg, qd, for 24 weeks

Atorvastatin

Vitamin E DRUG

Oral Vitamin E 300mg, qd, for 24 weeks

Vitamin E

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (-).
• kg/m2 ≤ BMI ≤ 40kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xin Gao: lead
• Pfizer: collaborator

Study Sites (1)

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Fatty Liver; Dyslipidemias; Diabetes Mellitus; Non-alcoholic Fatty Liver Disease

Interventions

Atorvastatin; Vitamin E

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xin Gao, doctor

  Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Gao, doctor

CONTACT

862164041990; gao.xin@zs-hospital.sh.cn; happy20061208@126.com

Hongmei Yan, doctor

CONTACT

13761666976; yan.hongmei@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Endocrinology and Metabolism, Zhongshan Hospital

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

CN (1)