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评估妊娠期糖尿病对后代心血管健康的影响:瑞士MySweetHeart队列研究方案

Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland.

作者信息

Di Bernardo Stefano, Mivelaz Yvan, Epure Adina Mihaela, Vial Yvan, Simeoni Umberto, Bovet Pascal, Estoppey Younes Sandrine, Chiolero Arnaud, Sekarski Nicole

机构信息

Paediatric Cardiology Unit, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland.

Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.

出版信息

BMJ Open. 2017 Nov 14;7(11):e016972. doi: 10.1136/bmjopen-2017-016972.

DOI:10.1136/bmjopen-2017-016972
PMID:29138200
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5695409/
Abstract

INTRODUCTION

Gestational diabetes mellitus (GDM) is a state of glucose intolerance with onset during pregnancy. GDM carries prenatal and perinatal risks as well as long-term risks for the mother and her child. GDM may be involved in the foetal programming of long-term cardiovascular health. However, evidence is sparse and the effect of GDM on cardiovascular health is unknown. To address these issues, we will conduct MySweetHeart Cohort study. The objectives are to assess the effect of GDM on offspring's cardiovascular health early in life by using surrogate markers of cardiovascular disease and atherosclerosis.

METHODS AND ANALYSIS

This is a cohort study of 100 offspring of women with GDM and 100 offspring of women without GDM. At inclusion, a baseline assessment of the mothers will be conducted through means of self-report questionnaires, a researcher-administrated interview, blood pressure and anthropometric measurements, and a maternal blood sampling. Between the 30th and 34th weeks of gestation, a foetal echography will be performed to assess the foetal cardiac structure and function, the fetomaternal circulation and the hepatic volume. At birth, maternal and neonatal characteristics will be assessed. An echocardiography will be performed to assess cardiac structure and function 2-7 days after birth; carotid intima-media thickness will be also measured to assess vascular structure. MySweetHeart Cohort is linked to MySweetHeart Trial (clinicaltrials.gov/ct2/show/NCT02890693), a randomised controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardiometabolic and mental health of women with GDM and their offspring. A long-term follow-up of children is planned.

ETHICS AND DISSEMINATION

Ethical approval has been obtained through the state Human Research Ethics Committee of the Canton de Vaud (study number 2016-00745). We aim to disseminate the findings through regional, national and international conferences and through peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov (clinicaltrials.gov/ct2/show/NCT02872974).

摘要

引言

妊娠期糖尿病(GDM)是一种在孕期出现的葡萄糖不耐受状态。GDM会给母亲及其孩子带来产前和围产期风险以及长期风险。GDM可能参与胎儿长期心血管健康的编程。然而,相关证据稀少,GDM对心血管健康的影响尚不清楚。为解决这些问题,我们将开展“MySweetHeart队列研究”。其目的是通过使用心血管疾病和动脉粥样硬化的替代标志物,评估GDM对后代早年心血管健康的影响。

方法与分析

这是一项队列研究,研究对象为100名患有GDM的女性的后代和100名未患GDM的女性的后代。纳入研究时,将通过自我报告问卷、研究人员主持的访谈、血压和人体测量以及母亲血液采样对母亲进行基线评估。在妊娠第30至34周期间,将进行胎儿超声心动图检查,以评估胎儿心脏结构和功能、母婴循环以及肝脏体积。出生时,将评估母亲和新生儿的特征。出生后2至7天将进行超声心动图检查以评估心脏结构和功能;还将测量颈动脉内膜中层厚度以评估血管结构。MySweetHeart队列与MySweetHeart试验(clinicaltrials.gov/ct2/show/NCT02890693)相关联,后者是一项随机对照试验,评估多维跨学科生活方式和心理社会干预对改善患有GDM的女性及其后代的心脏代谢和心理健康的效果。计划对儿童进行长期随访。

伦理与传播

已获得沃州国家人类研究伦理委员会的伦理批准(研究编号2016 - 00745)。我们旨在通过地区、国家和国际会议以及同行评审期刊传播研究结果。

试验注册号

ClinicalTrials.gov(clinicaltrials.gov/ct2/show/NCT02872974)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4e1/5695409/b56c47bc7be3/bmjopen-2017-016972f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4e1/5695409/b56c47bc7be3/bmjopen-2017-016972f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4e1/5695409/b56c47bc7be3/bmjopen-2017-016972f01.jpg

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