Cardiovascular Risk Factors, Lipid Metabolism and Oxidative Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213303
Recruitment Status : Active, not recruiting
First Posted : October 1, 2010
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Luigi Iuliano, University of Roma La Sapienza

Brief Summary:

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
Cardiovascular Disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
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

Blood donors
Evaluation of cardiovascular risk factors, oxidative stress and fatty acid metabolism in a cohort of blood donors

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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
Collection of plasma and serum samples

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of healthy blood donors

Inclusion Criteria:

  • Consecutive enrollment of blood donors

Exclusion Criteria:

  • Subjects with known chronic disease, including cardiovascular disease, liver disease, kidney disease, neurodegenerative disease and cancer; autoimmune disease, endocrine system disease,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01213303

Latina, Italy, 04100
Vascular Medicine Unit, Department of Medical Science and Biotechnology
Latina, Italy, 04100
Sponsors and Collaborators
University of Roma La Sapienza
Study Director: Luigi Iuliano, M.D., Ph.D. Sapienza University of Rome

Responsible Party: Luigi Iuliano, M.D., University of Roma La Sapienza Identifier: NCT01213303     History of Changes
Other Study ID Numbers: Iuliano_AVIS
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Luigi Iuliano, University of Roma La Sapienza:
cardiovascular risk
metabolic syndrome
fatty acids
oxidative stress

Additional relevant MeSH terms:
Cardiovascular Diseases