The effect of pioglitazone on circulating interleukin-۱۰ and tumor necrosis factor-alpha levels in a patient with metabolic syndrome: A randomized, double-blind controlled trial

BACKGROUND: This study aimed to evaluate the effect of pioglitazone as an insulin sensitizer on circulating interleukin-۱۰ (IL-۱۰) as an anti-inflammatory factor and tumor necrosis factor-alpha (TNF-α) as main proinflammatory factor in non-diabetic metabolic syndrome (MetS) patients in Caucasians race of Middle East area in Iran. METHODS: We conducted a randomized double-blind controlled study of ۶۸ non-diabetic patients with MetS. Patients were randomly divided into two groups including intervention group received pioglitazone ۳۰ mg daily for ۲۴ weeks, and the control group received placebo pills for the same duration. Circulating levels of TNF-α and IL-۱۰ were assessed as a primary goal. Lipid profile, liver enzymes, blood pressure (BP), waist circumference, and body mass index (BMI) also were measured. RESULTS: Lipid profile and fasting blood sugar had non-significant changes after treatment by pioglitazone, but BMI was increased significantly (P = ۰.۰۰۲). BP and waist circumference had a significant decrease in both groups (P < ۰.۰۵۰). Aspartate transaminase and alanine transaminase were decreased significantly in the pioglitazone group (P = ۰.۰۰۲). TNF-α decreased non-significantly in both groups (P > ۰.۰۵۰). IL-۱۰ increased in intervention group non-significantly (P = ۰.۹۷۱); whereas in placebo group decreased to a little extent (P = ۰.۴۰۱). C-reactive protein was also decreased insignificant after receive pioglitazone (P = ۰.۳۳۳). There was no significant difference in all variables between the two groups (P > ۰.۰۵۰) except liver enzymes (P < ۰.۰۵۰). CONCLUSION: This study indicates that the pioglitazone has no positive effect on improving inflammatory status in the non-diabetes patients with MetS.