The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis
Status:
Completed
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Recent studies have demonstrated that PPARĪ³ 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.
Phase:
Phase 2
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital