Completed

Association of Postprandial Triglyceride and Retinyl Palmitate Responses With Newly Diagnosed Exercise-induced Myocardial Ischemia in Middle-aged Men and Women

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arterial Occlusive Diseases+9

+ Arteriosclerosis

+ Brain Diseases

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: July 1990
See protocol details

Summary

Principal SponsorColumbia University
Last updated: December 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1990

Actual date on which the first participant was enrolled.

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.

NCT00005263
Principal SponsorColumbia University
Last updated: December 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

205 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisBrain DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesHeart DiseasesMyocardial IschemiaAtherosclerosis

Criteria

2 inclusion criteria required to participate
Men and Women 18 years and older

Undergoing diagnostic exercise electrocardiographic or thallium stress tests at our medical centers

2 exclusion criteria prevent from participating
Prior diagnosis of coronary artery disease (CAD)

Unable to fast due to health reasons

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Columbia University

New York, United StatesOpen Columbia University in Google Maps
CompletedOne Study Center