Status:
COMPLETED
Role of Pioglitazone and Berberine in Treatment of Non-Alcoholic Fatty Liver Disease
Lead Sponsor:
Xin Gao
Collaborating Sponsors:
Shanghai Jiao Tong University School of Medicine
Shanghai Municipal Science and Technology Commission
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). NAFLD is a group of diseases with to...
Eligibility Criteria
Inclusion
- Patients must have an age range between 18 to 65 years (inclusive).
- Patients with fatty liver confirmed by ultrasound.
- 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).
- Course of diabetic mellitus no more than 1 years
- 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
- Patients have not received lipid-regulating drugs (statins, fibrates)for 4 weeks before the time of enrollment
- Blood pressure \< 160/100 mmHg,after receiving lifestyle therapy and effective anti-hypertensive drugs.
- 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.
- 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
- 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.);
- Patients with significantly impaired liver function: ALT or AST ≥ 2 times upper limit of normal;
- HBsAg (+) and/or HCV-Ab (+);
- Patients with type 1 diabetes mellitus or gestational diabetes or special type diabetes, and patients with BMI \< 22 Kg/m2;
- Course of diabetes more than 1 years;
- Diabetics patients who have taken or are taking oral glucose-lowering drugs or insulin;
- Diabetics patients with a HbA1c \> 7.5% on initial visit;
- Patients with severe diabetes complications (diabetes ketoacidosis, diabetes coma or with symptomatic of diabetes coma; dysfunction of nerve, retinopathy, dysfunction of kidney）;
- Patients with serum creatinine ≥ 1.5 mg/dL (133 umol/L);
- Patients with a history of clinically significant heart disease (myocardial infarct, heart failure, and or severe cardiac rhythm);
- Complicating severe infection, within 6 months after operation, severe trauma;
- Patients with excess alcohol consumption≥140g/week(male); ≥ 70g/week(female);
- Patients have participated other clinical trials within 24 weeks;
- Patients with a history of drug allergy to TZDs and berberine;
- Patients wth gestation or possible gestation or lactation, or males or females who expecting gestation during clinical trial;
- Mental diseases patients;
- Those who refuse to sign informed consent;
- Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study;
- Patients with serum triglyceride ≥ 5.0 mmol/L;
- Patients with thyroid disease, including hyperthyroidism or hypothyroidism.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00633282
Start Date
March 1 2008
End Date
August 1 2011
Last Update
June 5 2012
Active Locations (3)
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1
Endocrinology and Metabolism Department, Zhongshan Hospital, Fudan University,
Shanghai, Shanghai Municipality, China, 200032
2
Department of Endocrinology and Metabolism,Shanghai Clinical Center of Diabetes,Shanghai Institute of Diabetes,The sixth people's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China, 200233
3
Department of Endocrinology and Metabolism,The Fifth People's Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200240