Abstract: Objective The aim of this clinical trial was to observe the short-term observation of metformin and pioglitazone combination in treatment of patients with non-alcoholic fatty liver diseases (NAFLD) and diabetes mellitus type 2 (T2DM). Methods 86 patients with NAFLD and T2DM were enrolled in our hospital between October 2018 and October 2020, and were divided randomly into control (n=43) and observation group (n=43). The patients in the control received metformin therapy and those in the observation were treated by metformin and pioglitazone combination therapy. The regimen lasted for 24 weeks. Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamyl transferase (GGT), total cholesterol (TC), triacylglycerol (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), fasting blood glucose (FPG) and glycosylated hemoglobin (HbA1c) were detected. Serum fasting insulin (FINS) level was detected by electrochemiluminescence method, and the homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. Results At the end of 24 week treatment and in the observation group, serum AST level was significantly lower than that in the control group [(37.9±4.2) U/L vs. (50.7±3.8) U/L, P<0.05], and serum GGT level was significantly lower than that in control group [(64.1±6.2) U/L vs. (73.1±7.0) U/L, P<0.05]; FPG level in observation group was significantly lower than that in control group [(6.0±1.2) mmol/L vs. (6.8± 1.5) mmol/L, P<0.05], HbA1c level was significantly lower than that in control group [(7.2±1.1)% vs. (7.7±1.3)%, P<0.05], and HOMA-IR level was significantly lower than that in control group [(2.4±0.5) vs. (2.9±0.5), P<0.05]; serum TG level was significantly lower than that in control group [(2.2±0.5) mmol/L vs. (2.6±0.4) mmol/L, P<0.05], LDL-C level was significantly lower than that in control group [(3.1±0.6) mmol/L vs. (3.5±0.8) mmol/L, P<0.05], while serum HDL-C level was significantly higher than that in control group [(1.5±0.3) mmol/L vs. (1.2±0.2) mmol/L, P<0.05]. Conclusion The application of metformin and pioglitazone combination in the treatment of patients with NAFLD and T2DM could effectively decrease blood glucose and insulin resistance levels, correct lipid metabolism disorders, which warrants further clinical investigation.

Key words: Non-alcoholic fatty liver disease, Type 2 diabetes mellitus, Metformin, Pioglitazone, Insulin resistance, Therapy