Last updated on March 2018

A clinical trial sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital for a research study of placebo, Pioglitazone


Brief description of study

Recent studies have demonstrated that PPAR 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:
  2. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver function tests.
  3. Evaluation of clinical safety of Pioglitazone
  4. Secondary aims:
  5. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation and fibrosis.
  6. 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).
  7. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive protein changes.
  8. Interventional aim: Assessment the association between magnetic resonance imaging study and intrahepatic fat distribution before and after Pioglitazone treatment.

Detailed Study 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 (PPAR) and by binding to the receptors of PPAR 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 PPAR as well as diet control could improve glycemic control, decrease serum ALT level, decrease hepatic fat distribution, and increase intrahepatic insulin sensitivity. Meanwhile, PPAR 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-PAR agonist among Asian peoples.

Clinical Study Identifier: NCT01068444

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