CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 184 enrolled
Drug / intervention
pioglitazone +2 moredrug
Likely dose
pioglitazone 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00633282
NCT00633282Phase 2Completed
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Role of Pioglitazone and Berberine in Treatment of Non-alcoholic Fatty Liver Disease(NAFLD) Patients With Impaired Glucose Regulation or Type 2 Diabetes Mellitus

Xin Gao·interventional·Posted Mar 12, 2008·Updated Jun 5, 2012

In Brief

A Phase 2 clinical trial evaluating Life style intervention, pioglitazone, and 1 other intervention for Nonalcoholic Fatty Liver Disease. Completed, enrolled 184 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Fatty Liver Disease
CountriesChina
CollaboratorsShanghai Jiao Tong University School of Medicine, Shanghai Municipal Science and Technology Commission

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2008
Enrollment StartMar 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.3 years ago

Interventions

Life style interventionbehavioral

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

pioglitazonedrug

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

berberinedrug

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