Skip to content

Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02872974
Enrollment
200
Registered
2016-08-19
Start date
2016-08-31
Completion date
2020-12-31
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Gestational Diabetes Mellitus

Keywords

Cardiovascular diseases, Gestational diabetes mellitus, Pediatrics, Fetal programming, Cohort study

Brief summary

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.

Interventions

OTHERGDM

Exposure to GDM during fetal life

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Left ventricular mass indexAt birth
Carotid intima-media thicknessAt birth

Secondary

MeasureTime frame
Fetal cardiovascular alterations30-34 wks of gestation (During fetal life)
Fetal left ventricular mass index30-34 wks of gestation (During fetal life)
Fetal liver volume30-34 wks of gestation (During fetal life)
Cardiovascular risk factorsAt birth

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026