产后妇女中二甲双胍预防妊娠糖尿病后 2 型糖尿病的效果（OMAhA）：一项英国多中心随机、安慰剂对照、双盲可行性试验及嵌套定性研究。

Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study.

机构信息

Institute of Lifecourse Development: Centre of Chronic Illness and Aging, Faculty of Education, Health & Human Sciences, University of Greenwich, London, UK

BARC (Barts Research Centre for Women's Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

出版信息

BMJ Open. 2023 Nov 28;13(11):e073813. doi: 10.1136/bmjopen-2023-073813.

DOI:10.1136/bmjopen-2023-073813

PMID:38016790

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10685917/

Abstract

OBJECTIVE

To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.

DESIGN

A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.

SETTING

Three inner-city UK National Health Service hospitals in London.

PARTICIPANTS

Pregnant women with gestational diabetes treated with medication.

INTERVENTIONS

2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.

PRIMARY OUTCOME MEASURES

Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.

SECONDARY OUTCOME MEASURES

Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.

RESULTS

Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.

CONCLUSIONS

It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

TRIAL REGISTRATION NUMBER

ISRCTN20930880.

摘要

目的

确定在患有妊娠期糖尿病的女性产后期间使用二甲双胍预防 2 型糖尿病的确定性试验的可行性。

设计

一项多中心、安慰剂对照、双盲随机可行性试验，并进行定性评估。

地点

伦敦三家英国国民保健署的市区内医院。

参与者

接受药物治疗的妊娠期糖尿病孕妇。

干预措施

从分娩到产后 1 年给予 2g 二甲双胍（干预组）或安慰剂（对照组）。

主要结局测量

招募率、随机分组率、随访率、失访率和对干预措施的依从性。

次要结局测量

血糖变化的初步估计、定性探索、干预措施的可接受性以及成本。

结果

在 302 名符合条件的女性中，57.9%（175/302）被招募。我们对招募的女性进行了 82.3%（144/175）的随机分组，其中 71 名女性在二甲双胍组，73 名女性在安慰剂组。在研究中仍有随访并提供任何依从性信息的参与者中，54.1%（59/109）服用了至少 75%的目标干预剂量；总体平均依从率为 64%（SD 33.6）。研究程序被女性和医疗保健专业人员认为是可以接受的。对发生 2 型糖尿病的风险增加的感知，或在怀孕期间服用二甲双胍的积极体验，鼓励了参与和对干预措施的依从。依从性的障碍包括在每次研究访问前的洗脱期导致药物计划中断，或每日提醒不足。