Abstract

Aim: Comprehensive (clinical, laboratory, instrumental) assessment of the clinical efficacy of metabolic disorders correction in patients with type 2 diabetes mellitus using a type 2 sodium-glucose cotransporter inhibitor. Design: Randomized comparative study. Materials and methods. A 26-week study included 130 patients with the presence of visceral obesity (56.3 ± 2.1 years) who did not reach the target parameters of glycated hemoglobin (HbA1c) on metformin monotherapy 2 g/day. The main group (68 people) received canagliflozin 300 mg/day, in combination with metformin 2 g/day; the control group (62 people) continued to receive monotherapy with metformin 2 g/day. At baseline and in 6 months, all patients underwent laboratory and instrumental examination methods, which included an assessment of carbohydrate metabolism (fasting glycemia (FG), postprandial glycemia (PPG), HbA1c); lipid profile (cholesterol levels, high and low density lipoproteins, triglycerides); content of adipocytokines- adiponectin (ADN), leptin (L). Visceral fat area (AVF) was assessed using a bioimpedance analyzer and magnetic resonance imaging (MRI) at the L4 level. Results. In 6 months, both groups showed significant positive dynamics of FG, PPG and HbA1c. In main group, HbA1c decreased by 2.7 ± 0.3% (p < 0.01), in control group by 0.2 ± 0.1% (p < 0.01). The FG and PPG levels in main group decreased by 4.5 ± 0.4 mmol/L (p < 0.01 ) and 5.8 ± 0.5 mmol/L (p < 0.01), respectively, in control group by 1.3 ± 0.2 mmol/L (p < 0.01) and 1.7 ± 0.4 mmol/L (p < 0.01). The level ADN in main group increased by 102.8 ± 4.8 mcg/ml (p < 0.01), in control group by 8.2 ± 2.1 mcg/ml (p < 0.01). L in main group decreased by 10.3 ± 0.9 ng/ml (p < 0.01), in control group by 4.1 ± 0.7 ng/ml (p < 0.01). In main group, there was a decrease in the VFA of by 18.6 ± 2.3 cm2 (p < 0.01) according to MRI, in control group by 4.7 ± 2.4 cm2 (p < 0.01). According to bioimpedance analysis, there was a decrease in the area of AVF by 26.7 ± 3.2 cm2 (p < 0.01) in the main group, and by 4.7 ± 2.5 cm2 (p < 0.01) in the control group. Conclusion. Combination therapy with canagliflozin and metformin makes it possible to achieve high clinical efficacy of carbohydrate metabolism correction in combination with a decrease in visceral fat depot and normalization levels of the main markers of metabolic health. Keywords: type 2 diabetes mellitus, leptin, adiponectin, canagliflozin.

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