Cardiovascular DiseasesNCT02872974
Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort
An observational study of Cardiovascular Diseases and Gestational Diabetes Mellitus, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Gestational Diabetes Mellitus
- What is being tested?
- GDM
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Women aged 18 yrs or older, with or without GDM at 24-32 weeks of gestation, and understanding French or English.
Who cannot join
- Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1005
About this study
Official title: 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.
Read more
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.
- Being tested
- GDM
- Keywords
- Cardiovascular diseases, Gestational diabetes mellitus, Pediatrics, Fetal programming, Cohort study
- Medical subject headings
- Cardiovascular Diseases, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDMOther
Exposure to GDM during fetal life
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Offspring of woman with GDM Receives: Other: GDM | |
| Not exposed | Offspring of woman without GDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass index
Measured: At birth
Carotid intima-media thickness
Measured: At birth
Secondary outcomes (4)
Fetal cardiovascular alterations
Measured: 30-34 wks of gestation (During fetal life)
Fetal left ventricular mass index
Measured: 30-34 wks of gestation (During fetal life)
Fetal liver volume
Measured: 30-34 wks of gestation (During fetal life)
Cardiovascular risk factors
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Sekarski, University of Lausanne Hospitals
- Investigators
- Nicole Sekarski, Prof, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872974
- Sponsor's protocol ID
- 2016-00745-C
- Other IDs
- 2016
- Status last verified
- Nov 2022
- First submitted
- 16 Aug 2016
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Plan to share data has to be defined
Publications
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.
PubMed 36443400Epure 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.
PubMed 35882452Horsch 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.
PubMed 29487077Di 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.
PubMed 29138200
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Maternal Gestational Diabetes on Offspring's Cardiovascular Health: MySweetHeart Cohort
- ClinicalTrials.gov ID
- NCT02872974
- Acronym / sponsor ID
- 2016-00745-C
- Keywords
- Cardiovascular diseases, Gestational diabetes mellitus, Pediatrics, Fetal programming, Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Other: GDMOffspring of woman with GDM |
| Not exposed | – | –Offspring of woman without GDM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women aged 18 yrs or older, with or without GDM at 24-32 weeks of gestation, and understanding French or English.
Key exclusion criteria (1 listed)
- Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDMExposure to GDM during fetal life | Other | Exposed |
Primary outcome
Left ventricular mass index
Time frame: At birth
Carotid intima-media thickness
Time frame: At birth
4 secondary outcomes
Fetal cardiovascular alterations
Time frame: 30-34 wks of gestation (During fetal life)
Fetal left ventricular mass index
Time frame: 30-34 wks of gestation (During fetal life)
Fetal liver volume
Time frame: 30-34 wks of gestation (During fetal life)
Cardiovascular risk factors
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 36443400Di 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.
- Derived from this study: PubMed 35882452Epure 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.
- Derived from this study: PubMed 29487077Horsch 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.
- Derived from this study: PubMed 29138200Di 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.
- Individual participant dataSharing planned: Yes. Plan to share data has to be defined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Sekarski, Prof principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Gestational Diabetes Mellitus, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass index (time frame: At birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872974, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.