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Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

This study is currently recruiting participants.
Verified October 2017 by Nicole Sekarski, University of Lausanne Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02872974
First Posted: August 19, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicole Sekarski, University of Lausanne Hospitals
  Purpose

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.


Condition Intervention
Cardiovascular Diseases Gestational Diabetes Mellitus Other: GDM

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consequences of Maternal Gestational Diabetes on Offspring's Cardiovascular Health: MySweetHeart Cohort

Further study details as provided by Nicole Sekarski, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Left ventricular mass index [ Time Frame: At birth ]
  • Carotid intima-media thickness [ Time Frame: At birth ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Not available

Estimated Enrollment: 200
Study Start Date: August 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed
Offspring of woman with GDM
Other: GDM
Exposure to GDM during fetal life
Not exposed
Offspring of woman without GDM

Detailed Description:
Not available
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872974


Contacts
Contact: Nicole Sekarski, Prof nicole.sekarski@chuv.ch
Contact: Arnaud Chiolero, MD PhD arnaud.chiolero@chuv.ch

Locations
Switzerland
Lausanne University Hospital Recruiting
Lausanne, Vaud, Switzerland, 1005
Contact: Nicole Sekarski, Prof       nicole.sekarski@chuv.ch   
Contact: Sandrine Estoppey       Sandrine.Estoppey@chuv.ch   
Principal Investigator: Nicole Sekarski, Prof         
Sub-Investigator: Yvan Mivelaz, MD         
Sub-Investigator: Stefano Di Bernardo, MD         
Sub-Investigator: Yvan Vial, MD         
Sub-Investigator: Pascal Bovet, Prof         
Sub-Investigator: Umberto Simeoni, Prof         
Sub-Investigator: Arnaud Chiolero, MD PhD         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Nicole Sekarski, Prof University of Lausanne Hospitals
  More Information

Responsible Party: Nicole Sekarski, Associate Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02872974     History of Changes
Other Study ID Numbers: 2016-00745-C
First Submitted: August 16, 2016
First Posted: August 19, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share data has to be defined

Keywords provided by Nicole Sekarski, University of Lausanne Hospitals:
Cardiovascular diseases
Gestational diabetes mellitus
Pediatrics
Fetal programming
Cohort study

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications