The Early Origins of Cardiovascular Disease
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 17, 2009 | ||||||||
| Last Updated Date | June 17, 2009 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Early Origins of Cardiovascular Disease | ||||||||
| Official Title ICMJE | The Early Origins of Cardiovascular Disease : the Consequence of Growth Restriction During Foetal Life and Infancy on Cardiovascular Structure and Function in Adulthood | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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 |
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| Condition ICMJE | Cardiovascular Disease | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Exposed/ Not exposed | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00923039 | ||||||||
| Other Study ID Numbers ICMJE | NU 304 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Dardaine /General representative, Danone Institute International | ||||||||
| Study Sponsor ICMJE | Danone Institute International | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Danone Institute International | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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