Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort
NCT ID: NCT02872974
Last Updated: 2022-11-02
Study Results
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Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2016-08-31
2020-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exposed
Offspring of woman with GDM
GDM
Exposure to GDM during fetal life
Not exposed
Offspring of woman without GDM
No interventions assigned to this group
Interventions
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GDM
Exposure to GDM during fetal life
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Nicole Sekarski
Associate Professor
Principal Investigators
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Nicole Sekarski, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
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Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
Countries
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References
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Di Bernardo SC, Lava SAG, Epure AM, Younes SE, Chiolero A, Sekarski N; MySweetHeart Research Group. Consequences of gestational diabetes mellitus on neonatal cardiovascular health: MySweetHeart Cohort study. Pediatr Res. 2023 Jul;94(1):231-238. doi: 10.1038/s41390-022-02390-4. Epub 2022 Nov 28.
Epure AM, Di Bernardo S, Mivelaz Y, Estoppey Younes S, Chiolero A, Sekarski N; MySweetHeart Research Group. Gestational diabetes mellitus and offspring's carotid intima-media thickness at birth: MySweetHeart Cohort study. BMJ Open. 2022 Jul 26;12(7):e061649. doi: 10.1136/bmjopen-2022-061649.
Horsch A, Gilbert L, Lanzi S, Gross J, Kayser B, Vial Y, Simeoni U, Hans D, Berney A, Scholz U, Barakat R, Puder JJ; MySweetHeart Research Group. Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial. BMJ Open. 2018 Feb 27;8(2):e020462. doi: 10.1136/bmjopen-2017-020462.
Di Bernardo S, Mivelaz Y, Epure AM, Vial Y, Simeoni U, Bovet P, Estoppey Younes S, Chiolero A, Sekarski N; MySweetHeart Research Group. Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland. BMJ Open. 2017 Nov 14;7(11):e016972. doi: 10.1136/bmjopen-2017-016972.
Other Identifiers
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2016-00745-C
Identifier Type: -
Identifier Source: org_study_id
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