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二甲双胍治疗 2 型糖尿病与维生素 D 水平:一项随机安慰剂对照试验的事后分析。

Long-term treatment with metformin in type 2 diabetes and vitamin D levels: A post-hoc analysis of a randomized placebo-controlled trial.

机构信息

Department of Internal Medicine, Bethesda Hospital Hoogeveen - Care Group Treant, Hoogeveen, The Netherlands.

Bethesda Diabetes Research Center Hoogeveen, Hoogeveen, The Netherlands.

出版信息

Diabetes Obes Metab. 2018 Aug;20(8):1951-1956. doi: 10.1111/dom.13327. Epub 2018 May 14.

Abstract

AIMS

To study the effects of metformin, as compared to placebo, on serum levels of vitamin D (25-hydroxyvitamin D [25(OH)D]) in patients with advanced type 2 diabetes.

MATERIALS AND METHODS

In the HOME trial, a randomized placebo-controlled trial, 390 insulin-treated patients with type 2 diabetes were treated with 850 mg metformin or placebo thrice daily for 52 months. In a post-hoc analysis, we examined changes in the combined levels of 25(OH)D and 25(OH)D at 4 and 16 months during the study.

RESULTS

Mean combined 25(OH)D at baseline was 68.2 nmoL/L (95% confidence interval [CI]: 65.5-71.1). In mixed model analysis, metformin, as compared to placebo, had no effect on 25(OH)D levels during 16 months (coefficient: 1.002 per month, multiplicative model; 95% CI: 0.998-1.006, P = .30). Metformin was associated with a small increase of 25(OH)D (coefficient: 1.012 per month; 95% CI: 1.003-1.021, P = .008). However, 25(OH)D is only a very small fraction (3%) of 25(OH)D. Seasonal variation had the biggest impact on 25(OH)D levels. Vitamin B12 levels were not associated with the levels of 25(OH)D.

CONCLUSION

Metformin had no effect on serum 25(OH)D during 16 months in the setting of a clinical randomized controlled trial in patients with type 2 diabetes. Our results show that metformin doesn't lead to vitamin D deficiency.

摘要

目的

研究与安慰剂相比,二甲双胍对 2 型糖尿病晚期患者血清维生素 D 水平(25-羟维生素 D [25(OH)D])的影响。

材料和方法

在 HOME 试验中,一项随机安慰剂对照试验,390 名接受胰岛素治疗的 2 型糖尿病患者每天服用 850mg 二甲双胍或安慰剂,持续 52 个月。在事后分析中,我们检查了研究期间 4 个月和 16 个月时 25(OH)D 和 25(OH)D 联合水平的变化。

结果

基线时平均联合 25(OH)D 为 68.2nmol/L(95%置信区间[CI]:65.5-71.1)。在混合模型分析中,与安慰剂相比,二甲双胍在 16 个月期间对 25(OH)D 水平没有影响(系数:每月 1.002,乘法模型;95%CI:0.998-1.006,P=0.30)。二甲双胍与 25(OH)D 的小幅度增加相关(系数:每月 1.012;95%CI:1.003-1.021,P=0.008)。然而,25(OH)D 只是 25(OH)D 的一小部分(3%)。季节性变化对 25(OH)D 水平的影响最大。维生素 B12 水平与 25(OH)D 水平无关。

结论

在 2 型糖尿病患者的临床随机对照试验中,二甲双胍在 16 个月期间对血清 25(OH)D 没有影响。我们的结果表明,二甲双胍不会导致维生素 D 缺乏。

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