The effect of vitamin K4 supplementation on insulin resistance in individuals with type 2 diabetes: a double-blind randomised placebo-controlled clinical trial

PurposeThe purpose of this study was to assess the possible clinical effects of vitamin K4 supplementation in individuals with type 2 diabetes namely insulin resistance, glycaemic control, and lipid profile.MethodsThis was a prospective randomised double-blind placebo-controlled clinical trial. A total of 106 patients were randomised to receive either 1 mg of vitamin K4 (menadiol diacetate) or placebo for 24 weeks.ResultsNinety patients (n = 45 in each study group) were included in the final analysis. After 24 weeks, homeostatic model assessment of insulin resistance (HOMA-IR) (16.54 & PLUSMN; 7.81 vs. 29.09 & PLUSMN; 36.56, P = 0.027) and fasting serum insulin (FSI) (6.86 & PLUSMN; 3.45 vs. 11.13 & PLUSMN; 12.66 & mu;U/ml, P = 0.032) were significantly lower in the vitamin K group compared to placebo. Additionally, triglycerides (TG) (144.94 & PLUSMN; 50.7 vs. 172.8 & PLUSMN; 101.5 mg/dl, P = 0.031) and very low-density lipoproteins (VLDL) levels (28.9 & PLUSMN; 9.88 vs. 34.6 & PLUSMN; 20.30 mg/dl, P = 0.027) decreased significantly in the vitamin K group after 24 weeks compared to baseline. Moreover, more patients in the vitamin K group (35.6%) had their antidiabetic medication doses reduced after 24 weeks compared to placebo (13.3%, P = 0.029).ConclusionVitamin K4 supplementation for 24 weeks is capable of improving insulin resistance and TG levels in individuals with type 2 diabetes. In addition, the improvement in insulin resistance was reflected in the decrease in antidiabetic medication doses. However, it did not affect fasting plasma glucose (FPG) or glycated haemoglobin (HbA(1)c).