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

NCT00633282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2012-06-05

No results posted yet for this study

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.

Conditions

  • Nonalcoholic Fatty Liver Disease

Interventions

BEHAVIORAL

Life style intervention

calorie limited diet: to subtract 500 kcal from daily mean calorie intake when entering the treatment activity: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate; or higher-intensity aerobic exercise for more than 90min per week with heart rate around 70% of the maximal heart rate

DRUG

pioglitazone

pioglitazone tablet,15mg qd ,30 minutes before breakfast,for 16 weeks

DRUG

berberine

berberine tablet 0.5g tid,30 minutes before each meal,for 16 weeks

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Municipal Science and Technology Commission

    collaborator OTHER_GOV

  • Xin Gao

    lead OTHER

Principal Investigators

  • Xin GAO, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633282 on ClinicalTrials.gov