ClinicalTrials.Veeva

Menu

Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

L

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Gestational Diabetes Mellitus
Cardiovascular Diseases

Treatments

Other: GDM

Study type

Observational

Funder types

Other

Identifiers

NCT02872974
2016-00745-C

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Exposed
Description:
Offspring of woman with GDM
Treatment:
Other: GDM
Not exposed
Description:
Offspring of woman without GDM

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems