Fatemeh Rahimi Sakak1, Nazanin Moslehi2, Mahtab Niroomand3, Parvin Mirmiran4,5. 1. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, No. 46, Arghavan-e-gharbi St., Farahzadi Blvd., Shahrak-e-qods, P.O.Box 19395-4741, Tehran, Iran. 2. Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No. 24, Shahid Arabi St, Yemen Blvd, Chamran Exp, Tehran, Iran. moslehinazanin@yahoo.com. 3. Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 4. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, No. 46, Arghavan-e-gharbi St., Farahzadi Blvd., Shahrak-e-qods, P.O.Box 19395-4741, Tehran, Iran. mirmiran@endocrine.ac.ir. 5. Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No. 24, Shahid Arabi St, Yemen Blvd, Chamran Exp, Tehran, Iran. mirmiran@endocrine.ac.ir.
Abstract
PURPOSE: This study aimed to investigate the effects of vitamin K2 supplementation in the form of menaquinone-7 (MK-7) on glucose, insulin, and lipid metabolism in patients with type 2 diabetes mellitus (T2DM). METHODS: In this double-blinded, placebo-controlled, randomized trial, 68 insulin-independent people with diabetes received either 180 µg MK-7 twice a day or placebo for 12 weeks. We assessed fasting plasma glucose (FPG) and insulin concentrations (primary outcomes), glycated hemoglobin (HbA1c), insulin sensitivity indices, and lipid profiles (secondary outcomes) at baseline and end of the trial. RESULTS: At the end of the trial, FPG (effect size (ES) = - 0.68; p-adjusted = 0.031) and HbA1c (ES = - 0.36; p-adjusted = 0.004) were significantly lower in the vitamin K2 group compared with the placebo at the end of the trial. The number of participants achieved the target levels of glycemic control based on FPG, and HbA1c concentrations were significantly higher in the vitamin K2 group compared to the placebo group. Insulin concentrations (ES = - 0.29; p = 0.019) and homeostatic model assessment for insulin resistance (HOMA-IR) significantly decreased in the vitamin K2 group (ES = - 0.29; p = 0.019) compared to baseline, but their values were not significantly different compared to the placebo group at the end of the trial. No significant variation was observed in lipid profiles. CONCLUSION: Daily intake of 360 µg Vitamin K2 in the form of MK-7 for 12-weeks reduces FPG and HbA1c in patients with T2DM but does not have a lipid-lowering effect.
RCT Entities:
PURPOSE: This study aimed to investigate the effects of vitamin K2 supplementation in the form of menaquinone-7 (MK-7) on glucose, insulin, and lipid metabolism in patients with type 2 diabetes mellitus (T2DM). METHODS: In this double-blinded, placebo-controlled, randomized trial, 68 insulin-independent people with diabetes received either 180 µg MK-7 twice a day or placebo for 12 weeks. We assessed fasting plasma glucose (FPG) and insulin concentrations (primary outcomes), glycated hemoglobin (HbA1c), insulin sensitivity indices, and lipid profiles (secondary outcomes) at baseline and end of the trial. RESULTS: At the end of the trial, FPG (effect size (ES) = - 0.68; p-adjusted = 0.031) and HbA1c (ES = - 0.36; p-adjusted = 0.004) were significantly lower in the vitamin K2 group compared with the placebo at the end of the trial. The number of participants achieved the target levels of glycemic control based on FPG, and HbA1c concentrations were significantly higher in the vitamin K2 group compared to the placebo group. Insulin concentrations (ES = - 0.29; p = 0.019) and homeostatic model assessment for insulin resistance (HOMA-IR) significantly decreased in the vitamin K2 group (ES = - 0.29; p = 0.019) compared to baseline, but their values were not significantly different compared to the placebo group at the end of the trial. No significant variation was observed in lipid profiles. CONCLUSION: Daily intake of 360 µg Vitamin K2 in the form of MK-7 for 12-weeks reduces FPG and HbA1c in patients with T2DM but does not have a lipid-lowering effect.
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