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The Early Origins of Cardiovascular Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Danone Institute International.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Danone Institute International
ClinicalTrials.gov Identifier:
NCT00923039
First received: June 17, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

Small body size at birth, slow weight gain during infancy and increase in body mass index after 2 years are independent risk factors for cardiovascular disease and the metabolic syndrome. There is a large gap in our understanding of how early growth affects the cardiovascular system. Possible mechanisms include alterations in body composition, in cardiac structure, in vascular function, in renal function and epigenetic processes.

The Objective is to determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics.


Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Early Origins of Cardiovascular Disease : the Consequence of Growth Restriction During Foetal Life and Infancy on Cardiovascular Structure and Function in Adulthood

Further study details as provided by Danone Institute International:

Primary Outcome Measures:
  • To determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2009
Groups/Cohorts
Exposed/ Not exposed

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

200 Young adult students will be recruited at the Preventive Medicine Centre at Université de la Méditerranée during their annual routine medical examination

Criteria

Inclusion Criteria:

  • Male and female volunteers students aged between 18-25 years old
  • Having growth records

Exclusion Criteria:

  • If young women subject without contraception,or pregnant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923039

Contacts
Contact: Umberto SIMEONI, MD,PhD 33 (0)4 91 38 40 30 umberto.simeoni@mail.ap-hm.fr
Contact: Olivier BLIN, MD,PhD 33 (0)4 91 38 75 63 olivier.blin@mail.ap-hm.fr

Locations
France
CIC-UPCET Hopital de la Timone Bat F Not yet recruiting
Marseille, France, 13385
Contact: Olivier BLIN, MD    +33 (0) 491 387 563    olivier.blin@ap-hm.fr   
Sponsors and Collaborators
Danone Institute International
  More Information

No publications provided

Responsible Party: Dardaine /General representative, Danone Institute International
ClinicalTrials.gov Identifier: NCT00923039     History of Changes
Other Study ID Numbers: NU 304
Study First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Danone Institute International:
The early origin of cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014