Effects of One Year Treatment of Sibutramine on Insulin Resistance Parameters in Type 2 Diabetic Patients
Purpose. Comparison of the effects of one year treatment with sibutramine compared to placebo on body weight, glycemic control, lipid profile, and insulin resistance parameters in type 2 diabetic patients. Methods. Two hundred and forty-six patients with uncontrolled type 2 diabetes mellitus in therapy with different oral hypoglycemic agents or insulin were enrolled in this study and randomised to take sibutramine 10 mg or placebo for one year. We evaluated at baseline, and after 3, 6, 9, and 12 months these parameters: body weight, body mass index (BMI), glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), retinol binding protein-4 (RBP-4), resistin, visfatin, and high sensitivity-C reactive protein (Hs-CRP). Results. We observed a faster improvement of HbA1c, FPG and PPG with sibutramine compared to the control group; furthermore we recorded a decrease of FPI, TC, LDL-C, body weight, and BMI in the sibutramine group, but not in the control group. A faster decrease of HOMA-IR, resistin, and RBP-4 was recorded with sibutramine compared to the control group. We observed a significant decrease of Hs-CRP in both groups. Conclusions. Sibutramine gave a faster improvement of glycemic control, and of insulin resistance parameters compared to placebo; furthermore sibutramine gave also an improvement of lipid profile, and body weight.