Epidemiology: Oxidative Stress and Early Atherosclerosis

Cardiovascular Diseases Clinical Trial

Official title:

Epidemiology: Oxidative Stress and Early Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005393
• Other study ID #: 4299
• Status: Completed
• Start date: August 1996
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white, male and female, high and low education individuals aged 18-30 in 1985-86. In subsequent renewals additional markers of oxidative stress and endothelial dysfunction have been measured in blood collected 7 to 30 years after baseline.

Description:

BACKGROUND:

Low blood antioxidant concentrations are associated with several major degenerative diseases including cardiovascular disease and cancer. Animal, cellular and chemical experiments have elucidated biologic mechanisms consistent with antioxidant protection against several disease processes. Determinants of blood antioxidant concentrations are not well understood in young adults.

The main scientific outcome of this research will be information on distribution and correlates of blood antioxidant concentrations, useful for formulating public health messages concerning maintenance of adequate levels of alpha tocopherol, selenium, ascorbic acid and the carotenoids.

DESIGN NARRATIVE:

An analysis was conducted using serum stored at 70 degrees Celsius, collected in 1985-86 (n=5115) and 1992-93 (n=4086). These analytes were stable in serum samples collected, handled and stored under conditions used in this study. Integrity of the chemical analysis throughout the study was maintained by proven laboratory quality control procedures. Monitoring analyte concentrations in serum from collections seven years apart allowed analysis of age and time dependent changes in serum antioxidants. These data were linked with extensive pre-existing sociodemographic, dietary, other behavioral and physiologic data for the cohort. Statistical analyses provided information on the population's serum antioxidant distribution, tracking, change and major determinants in diverse young adults. In addition, these data established baseline and 7-year change concentration values for followup of this large CARDIA cohort, though the relationship of these serum antioxidants to disease endpoints was not itself part of the work scope. Study of plasma ascorbic acid, which is not stable under our storage conditions, was initiated using fresh samples to be collected in 1995-96 (n=4000).

The Young Adult Longitudinal Study of Antioxidants (YALTA), ancillary to CARDIA study, was renewed in fiscal year 2000 to obtain additional blood and urine samples in the year 15 exam of the CARDIA participants. New measures of circulating lipid, protein, and DNA oxidation products (F2-isoprostanes, advanced glycosylation end-products [AGE], chlorinated and nitrosylated tyrosine, platelet aggregating factor (PAF) acetylhydrolase, paroxonase), urinary DNA damage, soluble intercellular adhesion molecule (ICAM), soluble P-selectin, and relevant genetic polymorphisms. The specific endpoints at the 15 year exam were coronary artery calcification as measured by computed tomography and microalbuminuria.

The study was renewed in 2004 through 2008. Blood and urine was collected from subjects at the CARDIA year 20 exam to remeasure blood F2 isoprostanes, phospholipase A2, superoxide dismutase and carotenoids and tocopherols. Oxidized low density lipoprotein (LDL) and myeloperoxidase was also measured and analysis conducted of the association of antioxidant and oxidative damage levels and the development of subclinical macrovascular disease in this still-young group.

The study renewed for a fourth time in 2010 through 2015, and a renewal application for a fifth renewal period was submitted in summer, 2014. It continues to write reports about different feature of oxidative stress and related phenomena as the CARDIA subjects age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5115
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 35 Years
• Eligibility: No eligibility criteria

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Cardiovascular Diseases
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Kaiser Permanente, Northwestern University, University of Alabama at Birmingham

References & Publications (4)

Lee DH, Gross MD, Jacobs DR Jr; Cardiovascular Risk Development in Young Adults Study. Association of serum carotenoids and tocopherols with gamma-glutamyltransferase: the Cardiovascular Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2004 Mar;50(3):582-8. Epub 2004 Jan 15. — View Citation

Lee DH, Jacobs DR Jr, Gross M, Kiefe CI, Roseman J, Lewis CE, Steffes M. Gamma-glutamyltransferase is a predictor of incident diabetes and hypertension: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2003 Aug;49(8):1358-66. — View Citation

Lee DH, Jacobs DR Jr, Gross M, Steffes M. Serum gamma-glutamyltransferase was differently associated with microalbuminuria by status of hypertension or diabetes: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2005 Jul;51(7):1185-91. Epub 2005 May 12. — View Citation

Svilaas A, Sakhi AK, Andersen LF, Svilaas T, Ström EC, Jacobs DR Jr, Ose L, Blomhoff R. Intakes of antioxidants in coffee, wine, and vegetables are correlated with plasma carotenoids in humans. J Nutr. 2004 Mar;134(3):562-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cardiovascular disease	Events are ascertained in annual direct contact with the participant. Medical records are obtained and adjudicated for event status.	Annual participant contact
Secondary	subclinical cardiovascular disease	Various subclinical measures are performed, including cardiac echocardiography and coronary computed tomography	every 5 years