Aguayo-Ruiz J I, García-Cobián T A, Pascoe-González S, Sánchez-Enríquez S, Llamas-Covarrubias I M, García-Iglesias T, López-Quintero A, Llamas-Covarrubias M A, Trujillo-Quiroz J, Rivera-Leon E A
Pharmacology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.
Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.
Diabetol Metab Syndr. 2020 Aug 18;12:73. doi: 10.1186/s13098-020-00580-w. eCollection 2020.
Patients with type 2 diabetes mellitus (T2DM) are characterized by chronic hyperglycemia as a consequence of decreased insulin sensitivity, which contributes to bone demineralization and could also be related to changes in serum levels of osteocalcin and insulin, particularly when coupled with a deficiency in the daily consumption of vitamins D3 and K2. The objective of this study was to evaluate the effect of vitamin D3 and vitamin K2 supplements alone or in combination on osteocalcin levels and metabolic parameters in patients with T2DM.
A double-blind, randomized clinical trial was carried out in 40 patients aged between 30 and 70 years old for 3 months. Clinical and laboratory assessment was carried out at the beginning and at the end of the treatment. The patients were divided into three groups: (a) 1000 IU vitamin D3 + a calcinated magnesium placebo (n = 16), (b) 100 µg of Vitamin K2 + a calcinated magnesium placebo (n = 12), and (c) 1000 IU vitamin D3 + 100 µg vitamin K2 (n = 12).
After treatment in the total studied population, a significant decrease in glycemia (p = 0.001), HOMA-IR (Homeostatic model assessment-insulin resistance) (p = 0.040), percentage of pancreatic beta cells (p < 0.001), uOC/cOC index and diastolic blood pressure (p = 0.030) were observed; in vitamin D3 group, differences in serum undercarboxylated osteocalcin (p = 0.026), undercarboxylated to carboxylated osteocalcin index (uOC/cOC) (p = 0.039) glucose (p < 0.001) and % of functional pancreatic beta cells (p < 0.001) were demonstrated. In vitamin K2 group a significant decrease in glycemia (p = 0.002), HOMA-IR (p = 0.041), percentage of pancreatic beta cells (p = 0.002), and in cOC (p = 0.041) were observed, conversely cOC concentration was found high. Finally, in the vitamins D3 + K2 a significant decrease in glycemia (p = 0.002), percentage of pancreatic beta cells (p = 0.004), and in the uOC/cOC index (p = 0.023) were observed.
Individual or combined supplementation with vitamins D3 and K2 significantly decreases the glucose levels and % of functional pancreatic beta cells, while D3 and D3 + K2 treatments also induced a reduction in the uOC/cOC index. Only in the group with vitamin D3 supplementation, it was observed a reduction in undercarboxylated osteocalcin while vitamin K2 increased the carboxylated osteocalcin levels. NCT04041492.
2型糖尿病（T2DM）患者的特征是由于胰岛素敏感性降低导致慢性高血糖，这会导致骨质脱矿，也可能与血清骨钙素和胰岛素水平的变化有关，特别是当每日维生素D3和K2摄入量不足时。本研究的目的是评估单独或联合补充维生素D3和维生素K2对T2DM患者骨钙素水平和代谢参数的影响。
对40名年龄在30至70岁之间的患者进行了为期3个月的双盲随机临床试验。在治疗开始和结束时进行临床和实验室评估。患者分为三组：（a）1000 IU维生素D3 + 煅烧镁安慰剂（n = 16），（b）100 μg维生素K2 + 煅烧镁安慰剂（n = 12），以及（c）1000 IU维生素D3 + 100 μg维生素K2（n = 12）。
在整个研究人群中治疗后，观察到血糖（p = 0.001）、HOMA-IR（稳态模型评估-胰岛素抵抗）（p = 0.040）、胰腺β细胞百分比（p < 0.001）、uOC/cOC指数和舒张压（p = 0.030）显著降低；在维生素D3组中，血清未羧化骨钙素（p = 0.026）、未羧化与羧化骨钙素指数（uOC/cOC）（p = 0.039）、血糖（p < 0.001）和功能性胰腺β细胞百分比（p < 0.001）存在差异。在维生素K2组中，观察到血糖（p = 0.002）、HOMA-IR（p = 0.041）、胰腺β细胞百分比（p = 0.002）和cOC（p = 0.041）显著降低，相反，cOC浓度较高。最后，在维生素D3 + K2组中，观察到血糖（p = 0.002）、胰腺β细胞百分比（p = 0.004）和uOC/cOC指数（p = 0.023）显著降低。
单独或联合补充维生素D3和K2可显著降低血糖水平和功能性胰腺β细胞百分比，而D3和D3 + K2治疗也可导致uOC/cOC指数降低。仅在补充维生素D3的组中，观察到未羧化骨钙素减少，而维生素K2可提高羧化骨钙素水平。NCT04041492。
