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Completed

NCT Number: NCT02872974

Gestational Diabetes and 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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Key information

Conditions

Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1005, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDM

Other

Exposure to GDM during fetal life

Primary outcomes

  1. Left ventricular mass index

    Time frame: At birth

  2. Carotid intima-media thickness

    Time frame: At birth

Secondary outcomes

  1. Fetal cardiovascular alterations

    Time frame: 30-34 wks of gestation (During fetal life)

  2. Fetal left ventricular mass index

    Time frame: 30-34 wks of gestation (During fetal life)

  3. Fetal liver volume

    Time frame: 30-34 wks of gestation (During fetal life)

  4. Cardiovascular risk factors

    Time frame: At birth

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2016
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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