Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	December 1987
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins
Official Title ^ICMJE	Lipoprotein Metabolism in Normal Volunteers and Dyslipoproteinemic Patients (Stable Isotopes)
Brief Summary	Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis). Patients participating in this study will receive an intravenous (directly into the vein) injection of a small amount of specially prepared amino acids. The amino acids being injected are the same amino acids present in a normal diet. The amount of amino acid given will be less than the amount eaten in a protein-rich meal. The amino acids will be labeled with nonradioactive heavy isotopes which are also present in the environment n low amounts. Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.
Detailed Description	Apolipoproteins regulate the metabolism of lipids and lipoproteins in plasma of humans. In order to investigate the roles of apolipoproteins in these processes, we plan to quantitate the kinetics of the metabolism of apolipoproteins utilizing nonradioactive isotope labeled amino-acids.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Healthy Hyperlipoproteinemia
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Gordon T, Castelli WP, Hjortland MC, Kannel WB, Dawber TR. High density lipoprotein as a protective factor against coronary heart disease. The Framingham Study. Am J Med. 1977 May;62(5):707-14. Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987 Jun 19;257(23):3233-40. Brown MS, Goldstein JL. A receptor-mediated pathway for cholesterol homeostasis. Science. 1986 Apr 4;232(4746):34-47. Review. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date	March 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	The subjects for these investigations will be either healthy normal volunteer control subjects or patients who have a dyslipoproteinemia. Subjects must be 18-80 years old.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001226
Responsible Party
Study ID Numbers ^ICMJE	870207, 87-H-0207
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	March 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP