- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00005263
Postprandial Lipoproteins and Atherosclerosis
Association of Postprandial Triglyceride and Retinyl Palmitate Responses With Newly Diagnosed Exercise-induced Myocardial Ischemia in Middle-aged Men and Women
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Prospettiva
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Henry Ginsberg, MD, Herbert and Florence Irving Professor of Medicine; Director, Columbia University Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
- Ginsberg HN, Jones J, Blaner WS, Thomas A, Karmally W, Fields L, Blood D, Begg MD. Association of postprandial triglyceride and retinyl palmitate responses with newly diagnosed exercise-induced myocardial ischemia in middle-aged men and women. Arterioscler Thromb Vasc Biol. 1995 Nov;15(11):1829-38. doi: 10.1161/01.atv.15.11.1829.
- Sharrett AR, Chambless LE, Heiss G, Paton CC, Patsch W. Association of postprandial triglyceride and retinyl palmitate responses with asymptomatic carotid artery atherosclerosis in middle-aged men and women. The Atherosclerosis Risk in Communities (ARIC) Study. Arterioscler Thromb Vasc Biol. 1995 Dec;15(12):2122-9. doi: 10.1161/01.atv.15.12.2122.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie vascolari
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattia coronarica
- Malattie cardiache
- Disfunsione dell'arteria coronaria
- Ischemia miocardica
- Malattia cardiovascolare
- Ischemia
- Malattie dell'arteria carotidea
- Aterosclerosi
Altri numeri di identificazione dello studio
- CUMC ID unknown (1147)
- U01HL045467 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .