Cardiovascular Risk Factors, Lipid Metabolism and Oxidative Stress

NCT01213303 | Unknown DMC

• 1 other identifier: Iuliano_AVIS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Disease

Keywords

cardiovascular risk; metabolic syndrome; fatty acids; oxysterols; antioxidants; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Fatty acids lipidomics and oxidative stress markers in healthy subjects

  Assessment of plasma reference values of the complete fatty acid profile, oxysterols and alpha- and gamma-tocopherol in healthy italian subjects

  21 months

Secondary Outcomes (2)

• Prevalence of fatty acids levels, in a complete panel, and markers of oxidative stress in subjects with metabolic syndrome

  21 months

• Ten-year follow-up

  ten years

Study Arms (1)

Blood donors

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy blood donors

You may qualify if:

• Consecutive enrollment of blood donors

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

AVIS

Latina, Latina, 04100, Italy

Location

Vascular Medicine Unit, Department of Medical Science and Biotechnology

Latina, Latina, 04100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of plasma and serum samples

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Luigi Iuliano, M.D., Ph.D.

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2021
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

IT (2)