Effect of Vitamin D Supplementation on Glycemic Control in Patients With Type 2 Diabetes (SUNNY Trial): A Randomized Placebo-Controlled Trial
Effect of Vitamin D Supplementation on Glycemic Control in Patients With Type 2 Diabetes (SUNNY Trial): A Randomized Placebo-Controlled Trial
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DOI：
10.2337/dc15-0323
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发表时间：
2015-08-01
期刊：
影响因子：
16.2
通讯作者：
Simsek, Suat
中科院分区：
文献类型：
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作者：
Krul-Poel, Yvonne H. M.;Westra, Sanne;Simsek, Suat
低维生素D状态与2型糖尿病患者血糖控制受损有关。我们研究的目的是评估维生素D补充对2型糖尿病患者血糖控制的影响。研究设计与方法This randomized，double-blind，placebo-controlled trial was carried out in 275 adult patients with type 2 diabetes without insulin treatment.患者被随机分配接受维生素D-3（50，000 IU/月）或安慰剂治疗6个月。为了评估研究的主要结果，HbA（1c）的变化，我们进行了线性回归分析。在维生素D和安慰剂组中，平均基线血清25-羟基维生素D [25（OH）D]从60.6 +/- 23.3增加到101.4 +/- 27.6 nmol/L和59.1 +/- 23.2增加到59.8 +/- 23.2 nmol/L，分别两组的平均基线HbA（1c）为6.8 ± 0.5%（51 ± 6 mmol/mol）。6个月后，在整个研究人群中，未观察到对HbA（1c）（平均差异：β = 0.4 [95% CI -0.6至1.5]; P = 0.42）和其他血糖控制指标（胰岛素抵抗、空腹胰岛素和血糖的HOMA）的影响。血清25（OH）D7%（53 mmol/mol）的患者亚组分析没有差异的results.CONCLUSIONSIn一个良好的控制组的2型糖尿病患者，间歇性高剂量维生素D补充剂没有改善血糖控制。
OBJECTIVELow vitamin D status has been associated with impaired glycemic control in patients with type 2 diabetes. The purpose of our study was to evaluate the effect of vitamin D supplementation on glycemic control in patients with type 2 diabetes.RESEARCH DESIGN AND METHODSThis randomized, double-blind, placebo-controlled trial was conducted in 275 adult patients with type 2 diabetes without insulin treatment. Patients were randomly assigned to receive either vitamin D-3 (50,000 IU/month) or placebo for 6 months. To assess the primary outcome of the study, change in HbA(1c), we performed a linear regression analysis.RESULTSMean baseline serum 25-hydroxyvitamin D [25(OH) D] increased from 60.6 +/- 23.3 to 101.4 +/- 27.6 nmol/L and 59.1 +/- 23.2 to 59.8 +/- 23.2 nmol/L in the vitamin D and placebo group, respectively. Mean baseline HbA(1c) was 6.8 +/- 0.5% (51 +/- 6 mmol/mol) in both groups. After 6 months, no effect was seen on HbA(1c) (mean difference: beta = 0.4 [95% CI -0.6 to 1.5]; P = 0.42) and other indicators of glycemic control (HOMA of insulin resistance, fasting insulin, and glucose) in the entire study population. Subgroup analysis in patients with a serum 25(OH) D7%(53 mmol/mol) did not differ the results.CONCLUSIONSIn a well-controlled group of patients with type 2 diabetes, intermittent high-dose vitamin D supplementation did not improve glycemic control.