Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005263
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2000-05-25
Brief Title:
Postprandial Lipoproteins and Atherosclerosis
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Association of Postprandial Triglyceride and Retinyl Palmitate Responses With Newly Diagnosed Exercise-induced Myocardial Ischemia in Middle-aged Men and Women
Status:
COMPLETED
Status Verified Date:
2015-12
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 determine whether postprandial lipoproteins were associated with atherosclerosis and if so whether the association was statistically independent of that between fasting lipoproteins and atherosclerosis
Detailed Description:
BACKGROUND
Fatty diets are a likely cause of atherosclerosis and lipoproteins appearing in blood after a fatty meal may be particularly atherogenic Yet nearly all published research up to 1990 on the relationship of blood lipids to atherosclerosis in humans measured lipids only in fasting or casual samples
The atherogenicity of postprandial lipoproteins particularly remnants of triglyceride-rich particles was suggested by in vitro studies of foam cell induction feeding experiments in animals and observations of Type III hyperlipoproteinemia in humans Indirect evidence for the hypothesis arose from research on conditions characterized by high fasting triglycerides and low HDL-cholesterol denser LDL particles and elevations of apolipoprotein B or intermediate-density lipoproteins The hypothesis received direct support from two small studies by Krauss in 1987 and Simons in 1987 which showed higher postprandial chylomicron remnant concentrations in coronary patients than controls However neither study had the statistical power to evaluate the relative associations of fasting and postprandial measurements with disease Such an evaluation because of close correlations between fasting and postprandial lipoproteins required studies with large sample sizes
The initiative originated in the Division of Epidemiology and Clinical Applications with input from the Division of Heart and Vascular Diseases and the two Divisions Advisory Groups and was approved in May 1989 by the National Heart Lung and Blood Advisory Council The Request for Applications was released in September 1989 Awards were made in July 1990
DESIGN NARRATIVE
Columbia University Cases and controls were recruited from individuals undergoing electrocardiographic examination or thallium stress testing Blood was taken before and during an eight hour period after ingestion of a fat-formula meal Plasma levels of lipids lipoproteins apoproteins lipolytic enzyme activities glucose and insulin were measured Apo E phenotype and LDL size were also determined These factors along with sex age blood pressure smoking status and waist-hip ratio were used as covariates in the analysis Postprandial remnant lipoproteins were also characterized
University of North Carolina Participants were administered an established and standardized fat challenge test containing vitamin A Food frequency history was also taken Blood specimens were drawn after fasting and at 35 and 9 hours after the test meal Various parameters of fasting and postprandial lipemia as well as markers for intestinal and hepatic triglyceride-rich lipoproteins were measured There were five consortia associated with the study the University of Minnesota Johns Hopkins University the University of Mississippi Bowman Gray School of Medicine and Baylor College of Medicine
Fatty diets are a likely cause of atherosclerosis and lipoproteins appearing in blood after a fatty meal may be particularly atherogenic Yet nearly all published research up to 1990 on the relationship of blood lipids to atherosclerosis in humans measured lipids only in fasting or casual samples
The atherogenicity of postprandial lipoproteins particularly remnants of triglyceride-rich particles was suggested by in vitro studies of foam cell induction feeding experiments in animals and observations of Type III hyperlipoproteinemia in humans Indirect evidence for the hypothesis arose from research on conditions characterized by high fasting triglycerides and low HDL-cholesterol denser LDL particles and elevations of apolipoprotein B or intermediate-density lipoproteins The hypothesis received direct support from two small studies by Krauss in 1987 and Simons in 1987 which showed higher postprandial chylomicron remnant concentrations in coronary patients than controls However neither study had the statistical power to evaluate the relative associations of fasting and postprandial measurements with disease Such an evaluation because of close correlations between fasting and postprandial lipoproteins required studies with large sample sizes
The initiative originated in the Division of Epidemiology and Clinical Applications with input from the Division of Heart and Vascular Diseases and the two Divisions Advisory Groups and was approved in May 1989 by the National Heart Lung and Blood Advisory Council The Request for Applications was released in September 1989 Awards were made in July 1990
DESIGN NARRATIVE
Columbia University Cases and controls were recruited from individuals undergoing electrocardiographic examination or thallium stress testing Blood was taken before and during an eight hour period after ingestion of a fat-formula meal Plasma levels of lipids lipoproteins apoproteins lipolytic enzyme activities glucose and insulin were measured Apo E phenotype and LDL size were also determined These factors along with sex age blood pressure smoking status and waist-hip ratio were used as covariates in the analysis Postprandial remnant lipoproteins were also characterized
University of North Carolina Participants were administered an established and standardized fat challenge test containing vitamin A Food frequency history was also taken Blood specimens were drawn after fasting and at 35 and 9 hours after the test meal Various parameters of fasting and postprandial lipemia as well as markers for intestinal and hepatic triglyceride-rich lipoproteins were measured There were five consortia associated with the study the University of Minnesota Johns Hopkins University the University of Mississippi Bowman Gray School of Medicine and Baylor College of Medicine
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL045467 | NIH | None | httpsreporternihgovquickSearchU01HL045467 |