Efficacy of metformin in pregnant obese women: a randomised controlled trial.
Efficacy of metformin in pregnant obese women: a randomised controlled trial.
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DOI：
10.1136/bmjopen-2014-006854
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发表时间：
2015-01-14
期刊：
影响因子：
2.9
通讯作者：
Norman JE
中科院分区：
文献类型：
--
作者：
Chiswick CA;Reynolds RM;Denison FC;Whyte SA;Drake AJ;Newby DE;Walker BR;Forbes S;Murray GD;Quenby S;Wray S;Norman JE
越来越多的证据表明，肥胖的根源在出生前。母亲肥胖、高出生体重与后代日后肥胖风险之间存在明显的相关性。同样清楚的是，怀孕期间肥胖的妇女发生不良后果的风险更大，包括妊娠糖尿病和死胎。肥胖引起这些问题的机制尚不清楚，尽管高脂血症和胰岛素抵抗是密切相关的。我们提出了一项研究方案，以检验二甲双胍将改善肥胖孕妇的胰岛素敏感性，从而降低高出生体重儿和其他妊娠并发症的发生率的假设。二甲双胍在妊娠肥胖妇女中的疗效，一项随机对照试验（EMPOWaR）是一项双盲随机安慰剂对照试验，旨在确定从妊娠16周至分娩期间给予肥胖（体重指数>30 kg/m2）妊娠妇女二甲双胍是否可降低高出生体重儿的发生率。 第二个目的是测试任何影响的机制。将在妊娠16周之前招募单胎妊娠且糖耐量正常的肥胖女性，并开出研究药物（二甲双胍或安慰剂），直至分娩。 进一步的研究访视将在妊娠28周和36周进行，以进行葡萄糖耐量试验并记录人体测量结果。 出生体重和其他测量结果将在分娩时记录。在产后3个月时进行母婴人体测量。 截至2014年1月，英国共有449名女性接受了随机分组。本研究将按照药物临床试验质量管理规范的原则进行。从苏格兰A研究伦理委员会获得了有利的伦理意见，参考编号10/MRE 00/12。研究结果将在会议上传播，并发表在同行评审的期刊上。ISRCTN51279843。
Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications. The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m2) pregnant women from 16 weeks’ gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks’ gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks’ gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK. The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals. ISRCTN51279843.
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DOI：
10.1136/bmj.f4539
发表时间：
2013-08-13
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Reynolds RM;Allan KM;Raja EA;Bhattacharya S;McNeill G;Hannaford PC;Sarwar N;Lee AJ;Bhattacharya S;Norman JE
通讯作者：
Norman JE
影响因子：
8
作者：
Boney, CM;Verma, A;Vohr, BR
通讯作者：
Vohr, BR
DOI：
10.1136/bmj.e2088
发表时间：
2012-05-16
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Thangaratinam S;Rogozinska E;Jolly K;Glinkowski S;Roseboom T;Tomlinson JW;Kunz R;Mol BW;Coomarasamy A;Khan KS
通讯作者：
Khan KS
DOI：
10.1111/j.1471-0528.2005.00437.x
发表时间：
2005-04-01
影响因子：
5.8
作者：
Kristensen, J;Vestergaard, M;Secher, NJ
通讯作者：
Secher, NJ
DOI：
10.1016/s0002-9378(03)00828-7
发表时间：
2003-12-01
影响因子：
9.8
作者：
Catalano, PM;Thomas, A;Amini, SB
通讯作者：
Amini, SB