Postprandial Lipoproteins and Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005263
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: July 2000
  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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1990
Estimated Study Completion Date: June 1993
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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005263

Sponsors and Collaborators
Investigators
Investigator: Gerardo Heiss
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005263     History of Changes
Other Study ID Numbers: 1147
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 22, 2014