The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis

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.

Timeline

Start

2009-04

Primary completion

2020-07

Completion

2020-07

Publications

• Huang JF, Dai CY, Huang CF, Tsai PC, Yeh ML, Hsu PY, Huang SF, Bair MJ, Hou NJ, Huang CI, Liang PC, Lin YH, Wang CW, Hsieh MY, Chen SC, Lin ZY, Yu ML, Chuang WL. First-in-Asian double-blind randomized trial to assess the efficacy and safety of insulin sensitizer in nonalcoholic steatohepatitis patients. Hepatol Int. 2021 Oct;15(5):1136-1147. doi: 10.1007/s12072-021-10242-2. Epub 2021 Aug 12.
• Huang JF, Yeh ML, Huang CF, Huang CI, Tsai PC, Tai CM, Yang HL, Dai CY, Hsieh MH, Chen SC, Yu ML, Chuang WL. Cytokeratin-18 and uric acid predicts disease severity in Taiwanese nonalcoholic steatohepatitis patients. PLoS One. 2017 May 4;12(5):e0174394. doi: 10.1371/journal.pone.0174394. eCollection 2017.

Drugs

Indications