Metformin has no major effects on glucose homeostasis in pregnant women with PCOS: results of a randomized double-blind study

Metformin has no major effects on glucose homeostasis in pregnant women with PCOS: results of a randomized double-blind study
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DOI:
10.1080/00365510802254620
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发表时间:
2008-01-01
影响因子:
2.1
通讯作者:
Carlsen, S. M.
Carlsen, S. M.
中科院分区:
医学4区
文献类型:
--
作者:
Fougner, K. J.;Vanky, E.;Carlsen, S. M.

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目标。先前的非随机和非对照研究表明,二甲双胍对多囊卵巢综合征(PCOS)孕妇的葡萄糖稳态有重要影响。我们在一项前瞻性对照研究中研究了二甲双胍对葡萄糖稳态的影响。材料和方法。40名患有多囊卵巢综合征且没有已知糖尿病的孕妇在妊娠早期被纳入研究,随机分为每日两次的850毫克二甲双胍组和安慰剂组。结果测量包括妊娠期的空腹血糖和胰岛素,妊娠19、32和36周的变化,以及妊娠期19和32周进行的75 g口服葡萄糖耐量试验(OGTT)期间的2小时血糖水平。采用稳态评估模型计算胰岛素抵抗(HOMA-IR)和β细胞功能(HOMA-beta)。结果。在纳入时,安慰剂组OGTT期间的2小时血糖水平更高(7.14 vs 6.03 mmol/L; p=0.012)。因此,二甲双胍组22名妇女中有6名在纳入时患有妊娠糖尿病,而安慰剂组18名妇女中有2名(p=0.21)。在妊娠第19周和第32周,两组间2小时血糖水平相等。妊娠期糖尿病妇女的总比例在两组之间没有差异,葡萄糖代谢和胰岛素抵抗的其他指标也没有差异。结论。二甲双胍似乎对多囊卵巢综合征孕妇的葡萄糖稳态没有重大影响。
Objective. Previous non-randomized and uncontrolled studies indicate major metformin effects on glucose homeostasis in pregnant women with polycystic ovary syndrome (PCOS). We investigated metformin effects on glucose homeostasis in a prospective controlled study. Material and methods. Forty pregnant women with PCOS and Without known diabetes mellitus were included in the first trimester and randomized to either metformin 850 mg twice daily or placebo. Outcome measures were fasting glucose and insulin at inclusion and changes to pregnancy weeks 19, 32 and 36 and 2 h glucose levels during a 75 g oral glucose tolerance test (OGTT) carried out at inclusion and pregnancy weeks 19 and 32. Insulin resistance (HOMA-IR) and beta-cell function (HOMA-beta) were calculated using the homeostasis assessment model. Results. At inclusion, 2 h glucose levels during OGTT were higher in the placebo group (7.14 versus 6.03 mmol/L; p=0.012). Accordingly, 6 out of 22 in the metformin group versus 2 out of 18 women in the placebo group (p=0.21) had gestational diabetes mellitus at inclusion. At gestational weeks 19 and 32, 2-h plasma glucose levels were equal between the groups. The total proportion of women with gestational diabetes did not differ between the groups, nor did any of the other indices of glucose metabolism and insulin resistance. Conclusions. Metformin seems to be without major effects on glucose homeostasis in pregnant women with PCOS.