Role of Pioglitazone and Berberine in Treatment of Non-Alcoholic Fatty Liver Disease

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects and safety of pioglitazone and berberine on the basis of lifestyle intervention to non-alcoholic fatty liver disease patients with impaired glucose regulation or type 2 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xin Gao
• Collaborators: Shanghai Jiao Tong University School of Medicine; Shanghai Municipal Science and Technology Commission
• Treatments: 2,4-thiazolidinedione; Pioglitazone

Criteria

Inclusion Criteria:

1. Patients must have an age range between 18 to 65 years (inclusive).

2. Patients with fatty liver confirmed by ultrasound.

3. Patients must meet the criteria for impaired glucose regulation or type 2 diabetes mellitus (FPG ≥ 5.6 mmol/L and/or a two hour glucose value ≥ 7.8 mmol/L).

4. Course of diabetic mellitus no more than 1 years

5. Diabetic patients have not received anti-diabetic drugs, including insulin, biguanides, sulfonylureas, thiazolidinediones, Alpha-glucosidase inhibitors, or glinides for 4 weeks before the time of enrollment

6. Patients have not received lipid-regulating drugs (statins, fibrates)for 4 weeks before the time of enrollment

7. Blood pressure < 160/100 mmHg,after receiving lifestyle therapy and effective anti-hypertensive drugs.

8. Patients must stopped other drugs medications for four weeks prior to entering the treatment period, such as: silybin, ursodeoxycholic acid, Polyene Phosphatidylcholine, vitamin E, some herbs with effect of regulating lipid and protecting liver function, etc.

9. Liver fat content(LFC) assessed by 1H MRS ≥ 13%(LFC was calculated by dividing the integral of the methylene groups in fatty acid chains of the hepatic triglycerides by the sum of methylene groups and water).

Exclusion Criteria:

1. Any causes of chronic liver disease other than NAFLD (such as - but not restricted to

• alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, etc.);

2. Patients with significantly impaired liver function: ALT or AST ≥ 2 times upper limit of normal;

3. HBsAg (+) and/or HCV-Ab (+);

4. Patients with type 1 diabetes mellitus or gestational diabetes or special type diabetes, and patients with BMI < 22 Kg/m2;

5. Course of diabetes more than 1 years;

6. Diabetics patients who have taken or are taking oral glucose-lowering drugs or insulin;

7. Diabetics patients with a HbA1c > 7.5% on initial visit;

8. Patients with severe diabetes complications (diabetes ketoacidosis, diabetes coma or with symptomatic of diabetes coma; dysfunction of nerve, retinopathy, dysfunction of kidney）;

9. Patients with serum creatinine ≥ 1.5 mg/dL (133 umol/L);

10. Patients with a history of clinically significant heart disease (myocardial infarct, heart failure, and or severe cardiac rhythm);

11. Complicating severe infection, within 6 months after operation, severe trauma;

12. Patients with excess alcohol consumption≥140g/week(male); ≥ 70g/week(female);

13. Patients have participated other clinical trials within 24 weeks;

14. Patients with a history of drug allergy to TZDs and berberine;

15. Patients wth gestation or possible gestation or lactation, or males or females who expecting gestation during clinical trial;

16. Mental diseases patients;

17. Those who refuse to sign informed consent;

18. Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study;

19. Patients with serum triglyceride ≥ 5.0 mmol/L;

20. Patients with thyroid disease, including hyperthyroidism or hypothyroidism.