Postprandial Lipoproteins and Atherosclerosis

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00005263
First received: May 25, 2000
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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.

Condition
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Carotid Artery Diseases
Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association of Postprandial Triglyceride and Retinyl Palmitate Responses With Newly Diagnosed Exercise-induced Myocardial Ischemia in Middle-aged Men and Women

Resource links provided by NLM:


Further study details as provided by Columbia University:

Enrollment: 205
Study Start Date: July 1990
Study Completion Date: November 1995
Primary Completion Date: November 1995 (Final data collection date for primary outcome measure)
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 3.5 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Populations undergoing diagnostic exercise electrocardiographic or thallium stress tests at our medical centers.
Criteria

Inclusion criteria

  • Men and Women 18 years and older
  • Undergoing diagnostic exercise electrocardiographic or thallium stress tests at our medical centers

Exclusion criteria

  • Prior diagnosis of coronary artery disease (CAD)
  • Unable to fast due to health reasons
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005263

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Henry Ginsberg, MD Herbert and Florence Irving Professor of Medicine; Director, Columbia University Medical Center
  More Information

Publications:
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00005263     History of Changes
Other Study ID Numbers: CUMC ID unknown (1147)  U01HL045467 
Study First Received: May 25, 2000
Last Updated: December 22, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Atherosclerosis
Myocardial Ischemia
Coronary Artery Disease
Carotid Artery Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2016