Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

NCT02872974 | Completed

• 1 other identifier: 2016-00745-C
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Gestational Diabetes Mellitus

Keywords

Cardiovascular diseases; Gestational diabetes mellitus; Pediatrics; Fetal programming; Cohort study

Outcome Measures

Primary Outcomes (2)

• Left ventricular mass index

  At birth

• Carotid intima-media thickness

  At birth

Secondary Outcomes (4)

• Fetal cardiovascular alterations

  30-34 wks of gestation (During fetal life)

• Fetal left ventricular mass index

  30-34 wks of gestation (During fetal life)

• Fetal liver volume

  30-34 wks of gestation (During fetal life)

• Cardiovascular risk factors

  At birth

Study Arms (2)

Exposed

Offspring of woman with GDM

Other: GDM

Not exposed

Offspring of woman without GDM

Interventions

GDM OTHER

Exposure to GDM during fetal life

Exposed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women aged 18 yrs or older, with or without GDM at 24-32 weeks of gestation, and understanding French or English.

You may not qualify if:

• Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 36443400 DERIVED

• 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.

  PMID: 35882452 DERIVED

• 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.

  PMID: 29487077 DERIVED

• 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.

  PMID: 29138200 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicole Sekarski, Prof

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)