Micronuclei frequency is a sensitive biomarker used to evaluate the genotoxicity induced by xenobiotics. Pioglitazone and glimepiride were associated with genotoxicity in experimental studies conducted in rats. Considering the lack of published reports on genotoxicity in T2DM patients using pioglitazone and glimepiride drugs in combination, current study aimed to assess whether the case and control groups significantly differ from each other in the frequency of micronuclei. Subjects comprise 127 T2DM patients (35-65 years old) under pioglitazone and glimepiride treatment for >5 years and control group of 140 age matched healthy controls (38-69 years old). Exfoliated oral mucosa cells were collected from buccal mucosa of all subjects and Feulgen/Fast-Green method was followed to screen for micronuclei. Factors such as gender, food habits, living areas and occupation have not shown significant association with the variation in micronuclei frequency among the studied subjects. However, T2DM patients under long term treatment of pioglitazone and glimepiride in combination, showed increased frequency of micronuclei as compared to controls (p<0.001). Current study suggests that the micronuclei assay can be used as a constituent among the panel of biomarkers to assess genotoxicity in T2DM patients under long term antihyperglycemic drug therapy.
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