Department of Epidemiology & Data Science, Amsterdam UMC - Location Vrije Universiteit, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands; Amsterdam Cardiovascular Sciences Research Institute, Amsterdam, the Netherlands.
Department of Epidemiology & Data Science, Amsterdam UMC - Location Vrije Universiteit, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands; Amsterdam Cardiovascular Sciences Research Institute, Amsterdam, the Netherlands.
Atherosclerosis. 2024 Jul;394:117307. doi: 10.1016/j.atherosclerosis.2023.117307. Epub 2023 Oct 6.
BACKGROUND AND AIMS: Experimental studies suggested that vitamin K supplementation may retard arterial calcification. Recently, serum calcification propensity time (T) has been suggested as a functional biomarker for arterial wall calcification propensity. In this post-hoc analysis of a clinical trial, we evaluated the effect of six-month oral vitamin K supplementation on T and assessed the correlation between T and imaging arterial calcification parameters in people with type 2 diabetes (T2DM). METHODS: This double-blind, randomized, placebo-controlled trial included 68 participants (age = 69 ± 8 years, 76% male) with T2DM. Participants were assigned to menaquinone-7 (360 μg/day; n = 35) or placebo (n = 33). T was measured via nephelometry in serum collected at baseline, three and six months. Arterial calcification was measured at baseline and six months via F-Na PET-CT and conventional CT using Target-to-Background ratio (TBR) and Agatston score. Longitudinal analysis of covariance adjusted for baseline T was used to study the treatment effect. Spearman's correlation was used to assess the correlation between T and imaging calcification parameters. RESULTS: Median baseline T was similar in the vitamin K (350 [321-394] minutes) and placebo groups (363 [320-398]). There was no significant difference in T between treatment arms over time (ẞ = 1.00, 95%C.I. = 0.94-1.07, p = 0.982). The correlation coefficient of T with TBR and Agatston score at baseline were -0.185 (p = 0.156) and -0.121 (p = 0.358), respectively. CONCLUSIONS: No effect of vitamin K supplementation on T was observed in T2DM. Moreover, T did not correlate with TBR and Agatston score. Further research on vitamin K in arterial calcification and on the validity of T as arterial calcification marker is warranted.
背景与目的：实验研究表明，维生素 K 补充可能会延缓动脉钙化。最近，血清钙化倾向时间（T）被认为是动脉壁钙化倾向的功能性生物标志物。在这项临床试验的事后分析中，我们评估了六个月口服维生素 K 补充对 T 的影响，并评估了 T 与 2 型糖尿病（T2DM）患者的影像学动脉钙化参数之间的相关性。 方法：这项双盲、随机、安慰剂对照试验纳入了 68 名（年龄=69±8 岁，76%为男性）T2DM 患者。患者被分配至甲萘醌-7（360μg/天；n=35）或安慰剂（n=33）组。T 通过基线、三个月和六个月时采集的血清中的散射光测量法进行测量。动脉钙化通过 F-Na PET-CT 和常规 CT 采用靶-背景比（TBR）和 Agatston 评分在基线和六个月时进行测量。使用协方差分析对 T 进行基线调整，以研究治疗效果。采用斯皮尔曼相关性分析评估 T 与影像学钙化参数之间的相关性。 结果：维生素 K（350[321-394]分钟）和安慰剂组的 T 中位数在基线时相似。治疗组之间 T 随时间的变化没有显著差异（ß=1.00，95%CI=0.94-1.07，p=0.982）。T 与基线时 TBR 和 Agatston 评分的相关系数分别为-0.185（p=0.156）和-0.121（p=0.358）。 结论：在 T2DM 中，维生素 K 补充对 T 没有影响。此外，T 与 TBR 和 Agatston 评分无相关性。需要进一步研究维生素 K 在动脉钙化中的作用以及 T 作为动脉钙化标志物的有效性。
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