The Early Origins of Cardiovascular Disease

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00923039
• Other study ID #: NU 304
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2009
• Last updated: June 17, 2009
• Start date: June 2009

Study information

• Verified date: June 2009
• Source: Danone Institute International
• Contact: Umberto SIMEONI, MD,PhD
• Phone: 33 (0)4 91 38 40 30
• Email: umberto.simeoni[@]mail.ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
France	CIC-UPCET Hopital de la Timone Bat F	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Danone Institute International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 years	No