Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005393
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2000-05-25
Brief Title:
Epidemiology Oxidative Stress and Early Atherosclerosis
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Epidemiology Oxidative Stress and Early Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 n5115 and 1992-93 n4086 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 populations 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 n4000
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
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 n5115 and 1992-93 n4086 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 populations 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 n4000
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None