Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

Study Overview
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Brief Summary
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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.

Official Title
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Consequences of Maternal Gestational Diabetes on Offspring's Cardiovascular Health: MySweetHeart Cohort

Conditions
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Cardiovascular Diseases, Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: GDM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 yrs or older, with or without GDM at 24-32 weeks of gestation, and understanding French or English. Exclusion Criteria: Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Offspring of woman with GDM | Other: GDM<br>* Exposure to GDM during fetal life<br>|
| Not exposed<br>Offspring of woman without GDM | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mass index |  | At birth | 
| Carotid intima-media thickness |  | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal cardiovascular alterations |  | 30-34 wks of gestation (During fetal life) | 
| Fetal left ventricular mass index |  | 30-34 wks of gestation (During fetal life) | 
| Fetal liver volume |  | 30-34 wks of gestation (During fetal life) | 
| Cardiovascular risk factors |  | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular diseases, Gestational diabetes mellitus, Pediatrics, Fetal programming, Cohort study