Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

Completed

• Conditions: Cardiovascular Diseases; Gestational Diabetes Mellitus
• Interventions: Other: GDM

• Registration Number: NCT02872974
• Lead Sponsor: University of Lausanne Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	GDM	Offspring of woman with GDM

Primary Outcome Measures

Name	Time	Method
Left ventricular mass index	At birth
Carotid intima-media thickness	At birth

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland