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The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis

NCT01068444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-07-23

No results posted yet for this study

Summary

Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic control, decrease serum ALT level, decrease hepatic fat distribution, and increase intrahepatic insulin sensitivity. The purposes of this study are:

1\. Primary aims:

1. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver function tests.
2. Evaluation of clinical safety of Pioglitazone

2\. Secondary aims:

1. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation and fibrosis.
2. The impact of Pioglitazone on the related metabolic index, including insulin resistance(HOMA-IR), newly-onset diabetes, metabolic syndrome, lipid profiles (T-Chol, HDL-C, LDL-C, TG).
3. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive protein changes.

3\. Interventional aim: Assessment the association between magnetic resonance imaging study and intrahepatic fat distribution before and after Pioglitazone treatment.

Conditions

  • Hepatitis

Interventions

DRUG

Pioglitazone

1. Name: GLITOS（Pioglitazone） 2. Dosage form: Tablets 3. Dose(s): 30mg 4. Dosing schedule: QD 5. Duration: 6 months

DRUG

placebo

placebo 30 mg/d for 6 months

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Wan-Long Chuang, MD, PhD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT01068444 on ClinicalTrials.gov