Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

November 1, 2022 updated by: Nicole Sekarski, University of Lausanne Hospitals

Consequences of Maternal Gestational Diabetes on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1005
        • Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will include the offspring of 100 women with GDM and of 100 women without GDM. They will be recruited at 24-32 wks of gestation and will be followed-up with their offspring until birth. Primary outcomes will be measured shortly (2-7 days) after birth. Secondary outcomes will be measured during the foetal period (30-34 wks of gestation), at birth, and shortly (2-4 days) after birth. A long-term follow-up of these children is planned.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed
Offspring of woman with GDM
Other: GDM
Exposure to GDM during fetal life
Not exposed
Offspring of woman without GDM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Nicole Sekarski, Prof, University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (ESTIMATE)

August 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00745-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share data has to be defined

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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