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

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 June 18, 2013

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