Cardiovascular Diseases Clinical Trial
Official title:
Consequences of Maternal Gestational Diabetes on Offspring's Cardiovascular Health: MySweetHeart Cohort
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.
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