Cardiovascular Risk Factors, Lipid Metabolism and Oxidative Stress
|ClinicalTrials.gov Identifier: NCT01213303|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2010
Last Update Posted : December 11, 2015
Cardiovascular diseases belong to the major causes of mortality in western populations, and atherosclerosis is the lesion responsible for clinical events, such as acute myocardial infarction and stroke.
Atherosclerosis remains asymptomatic until a clinical event occurs, and in the pre-clinical stage it may be difficult to diagnose. As disease surrogate, a large number of risk factors for atherosclerosis are being recognized. Some of them are responsible for the epidemiologically very serious metabolic syndrome, which accounts for development of hyperlipidemia, obesity, diabetes or arterial hypertension.
Health providers in continental diet-based countries suggest to embracing Mediterranean diet in order to contribute in reducing cardiovascular mortality. However, countries in the Mediterranean area are experiencing a shift in dietary habit towards continental diet with potential harmful change in mortality rates. Oxidative stress, including free radical-driven reactions and antioxidant status are considered important mediators to be considered in the diet-mediated effect on health. Important metabolic functions are also mediated by certain fatty acids. A comprehensive study of oxidative stress, including free radical-driven products and protective antioxidants, and fatty acids metabolism has never been reported in healthy subjects. In particular, high sensitive mass-spectrometry methods to study oxidative stress and fatty acids metabolism are rarely applied to epidemiological studies.
The aim of the present grant project is therefore to assess in a large cross-sectional study the prevalence of oxidative stress markers, and fatty acids and to find any causal relation between these variables and metabolic syndrome. This population sample will be followed prospectively not only for time of the present grant project, but we would like to study metabolic variables with relation to the development of oxidative stress-mediated diseases, in particular those of cardiovascular system, on a longitudinal basis (prospective epidemiological study for at least 10 years). At same time we should be able to define the importance of individual markers of oxidative stress and fatty acids for early detection of these diseases.
|Condition or disease|
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|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Relation Between Fatty Acids and Oxidative Stress Markers With Cardiovascular Risk Factors in a Healthy Population|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2021|
Evaluation of cardiovascular risk factors, oxidative stress and fatty acid metabolism in a cohort of blood donors
- Fatty acids lipidomics and oxidative stress markers in healthy subjects [ Time Frame: 21 months ]Assessment of plasma reference values of the complete fatty acid profile, oxysterols and alpha- and gamma-tocopherol in healthy italian subjects
- Prevalence of fatty acids levels, in a complete panel, and markers of oxidative stress in subjects with metabolic syndrome [ Time Frame: 21 months ]The assessment of the complete fatty acids profile, oxysterols and vitamin E (alpha- and gamma-tocopherol) would reveal associations with components cardiovascular risk factors of the metabolic syndrome
- Ten-year follow-up [ Time Frame: ten years ]Prospective evaluation of cardiovascular events as function of baseline fatty acids and oxidative stress
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213303
|Latina, Italy, 04100|
|Vascular Medicine Unit, Department of Medical Science and Biotechnology|
|Latina, Italy, 04100|
|Study Director:||Luigi Iuliano, M.D., Ph.D.||Sapienza University of Rome|