The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis

Phase 2

Completed

• Conditions: Hepatitis
• Interventions: Drug: placebo; Drug: Pioglitazone

• Registration Number: NCT01068444
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Detailed Description

Pioglitazone belongs to thiazolidinediones and anti-diabetes drug which decreases the insulin resistance. It increases the use of glucose of peripheral tissues and decrease the production of glucose from liver and dose not influence the production of insulin. It is agonist of peroxisome proliferator-activated receptor-gamma (PPARγ) and by binding to the receptors of PPARγ in various tissues it has effects on transcription of the insulin-dependent gene. In animal model, pioglitazone has shown to influence the metabolism by the insulin-dependent mechanism.

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. Meanwhile, PPARγ could also prevent the development of alcohol-induced steatohepatitis, improve hepatic necroinflammatory activity, and decrease lipid deposition. It is not yet clearly known how the effect of P-PARγ agonist among Asian peoples.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Status Verified: 2020-07
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo 30 mg/day for 6 months and 3 months of follow-up period after treatment
Pioglitazone	Pioglitazone	Pioglitazone 30 mg/day for 6 months and 3 months of follow-up period after treatment

Primary Outcome Measures

Name	Time	Method
Evaluation of clinical safety of Pioglitazone	9 months
Comparison between Pioglitazone and placebo groups in terms of steatosis and liver function tests	9 months

Secondary Outcome Measures

Name	Time	Method
Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation and fibrosis.	9 months

Trial Locations

Locations (2)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University; 🇨🇳 Kaohsiung City, Taiwan