Consequences of Maternal Gestational Diabetes on Offspring's Cardiovascular Health: MySweetHeart Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Left ventricular mass index
研究概览
简要总结
MySweetHeart Cohort is an observational study to assess the effect of gestational diabetes mellitus (GDM) on early life offspring's cardiovascular health.
The primary objective is to assess the effect of GDM on the surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical atherosclerosis). The secondary objective is to assess the effect of GDM on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.
The main hypothesis is that offspring of women with GDM have a larger LVMI and a larger cIMT at birth (primary outcomes) compared with offspring of women without GDM. Further, other hypotheses are that offspring of women with GDM have more foetal cardiovascular alterations and adverse neonatal cardio-metabolic risk factors (secondary outcomes) compared with offspring of women without GDM.
My SweetHeart Cohort is linked to MySweetHeart Trial, a randomized controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring. The principal investigators of this trial are Prof Jardena Puder and Dr Antje Horsch from Lausanne University Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 yrs or older, with or without GDM at 24-32 weeks of gestation, and understanding French or English.
排除标准
- •Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder
结局指标
主要结局
Left ventricular mass index
时间窗: At birth
Carotid intima-media thickness
时间窗: At birth
次要结局
- Cardiovascular risk factors(At birth)
- Fetal left ventricular mass index(30-34 wks of gestation (During fetal life))
- Fetal cardiovascular alterations(30-34 wks of gestation (During fetal life))
- Fetal liver volume(30-34 wks of gestation (During fetal life))
研究者
Nicole Sekarski
Associate Professor
University of Lausanne Hospitals