A randomised controlled trial of high dose vitamin D in recent-onset type 2 diabetes

A randomised controlled trial of high dose vitamin D in recent-onset type 2 diabetes
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DOI:
10.1016/j.diabres.2014.08.030
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发表时间:
2014-12-01
影响因子:
5.1
通讯作者:
Fourlanos, Spiros
Fourlanos, Spiros
中科院分区:
医学3区
文献类型:
--
作者:
Elkassaby, Shirley;Harrison, Leonard C.;Fourlanos, Spiros

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目的:维生素D缺乏与胰岛β细胞功能受损有关。我们的目的是确定大剂量口服维生素D3(D)是否能改善2型糖尿病患者的β细胞功能和血糖。方法:50例确诊为12个月以下的2型糖尿病患者,基线血清25-羟基D(25D)正常,随机分为6000IU D(n=26)和安慰剂(n=24),每天服用6000 IU D(n=26)或安慰剂(n=24)。用胰高血糖素刺激的血清C肽(DCP)测定胰岛β细胞功能。次要观察指标为空腹血糖、餐后血糖、糖化血红蛋白和胰岛素抵抗(HOMA-IR)。结果:D组血清25D中位数由59增至150(3个月)和128(6个月),1,25D(pmol/L)由135增至200和190。3个月后,D组(+0.04)和安慰剂组(-0.08)的DCP变化与基线无差异(P=0.112)。然而,D组的空腹血糖变化(摩尔/L)显著低于安慰剂组(-0.40)(P=0.007),以及D组的脉压变化(-0.30)比安慰剂组(+0.8)低(P=0.005)。D组(-0.20)和安慰剂组(-0.10)之间的HbA1c(%)变化无差异(P=0.459)。在6个月时,DCP、FPG、PPG和HbA1c的变化在两组之间没有差异。结论:口服D3与2型糖尿病患者血糖的短暂改善有关,但如果β细胞功能没有可测量的变化,这种影响不太可能具有生物学意义。因此,大剂量的D3对2型糖尿病的治疗效果似乎很小,甚至没有。(C)2014爱思唯尔爱尔兰有限公司。保留所有权利。
Aims: Vitamin D insufficiency has been associated with impaired pancreatic beta-cell function. We aimed to determine if high dose oral vitamin D3 (D) improves beta-cell function and glycaemia in type 2 diabetes.Methods: Fifty adults with type 2 diabetes diagnosed less than 12 months, with normal baseline serum 25-OH D (25D), were randomised to 6000 IU D (n = 26) or placebo (n = 24) daily for 6 months. Beta-cell function was measured by glucagon-stimulated serum C-peptide (delta C-peptide [DCP], nmol/l). Secondary outcome measures were fasting plasma glucose (FPG), post-prandial blood glucose (PPG), HbA1c and insulin resistance (HOMA-IR).Results: In the D group, median serum 25D (nmol/l) increased from 59 to 150 (3 months) and 128 (6 months) and median serum 1,25D (pmol/l) from 135 to 200 and 190. After 3 months, change in DCP from baseline in D (+0.04) and placebo (-0.08) was not different (P = 0.112). However, change in FPG (mmol/l) was significantly lower in D (-0.40) compared to placebo (+0.1) (P = 0.007), as was the change in PPG in D (-0.30) compared to placebo (+0.8) (P = 0.005). Change in HbA1c (%) between D (-0.20) and placebo (-0.10) was not different (P = 0.459). At 6 months, changes from baseline in DCP, FPG, PPG and HbA1c were not different between groups.Conclusion: Oral D3 supplementation in type 2 diabetes was associated with transient improvement in glycaemia, but without a measurable change in beta-cell function this effect is unlikely to be biologically significant. High dose D3 therefore appears to offer little or no therapeutic benefit in type 2 diabetes. (C) 2014 Elsevier Ireland Ltd. All rights reserved.