Epidemiology: Oxidative Stress and Early Atherosclerosis

NCT ID: NCT00005393

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5115 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-08-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Arteriosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

No eligibility criteria
Minimum Eligible Age

17 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David R Jacobs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Myron D Gross, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1373/49.8.1358.

Reference Type BACKGROUND
PMID: 12881453 (View on PubMed)

Svilaas A, Sakhi AK, Andersen LF, Svilaas T, Strom 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. doi: 10.1093/jn/134.3.562.

Reference Type BACKGROUND
PMID: 14988447 (View on PubMed)

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. doi: 10.1373/clinchem.2003.028852. Epub 2004 Jan 15.

Reference Type BACKGROUND
PMID: 14726472 (View on PubMed)

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. doi: 10.1373/clinchem.2004.045872. Epub 2005 May 12.

Reference Type BACKGROUND
PMID: 15890893 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4299

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Epidemiology of Atherosclerosis
NCT00005147 COMPLETED