Hepatitis Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis
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.
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.
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