Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins
Primary Purpose
Healthy, Hyperlipoproteinemia
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Healthy focused on measuring Nonradioactive Isotopes, Lipoprotein Kinetics, Apolipoproteins, Dyslipoproteinemia, Healthy Volunteers
Eligibility Criteria
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.
Sites / Locations
- National Heart, Lung and Blood Institute (NHLBI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001226
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00001226
Brief Title
Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins
Official Title
Lipoprotein Metabolism in Normal Volunteers and Dyslipoproteinemic Patients (Stable Isotopes)
Study Type
Observational
2. Study Status
Record Verification Date
March 2002
Overall Recruitment Status
Completed
Study Start Date
December 1987 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hyperlipoproteinemia
Keywords
Nonradioactive Isotopes, Lipoprotein Kinetics, Apolipoproteins, Dyslipoproteinemia, Healthy Volunteers
7. Study Design
Enrollment
90 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
193398
Citation
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. doi: 10.1016/0002-9343(77)90874-9.
Results Reference
background
PubMed Identifier
3295315
Citation
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. Erratum In: JAMA 1988 May 13;259(18):2698.
Results Reference
background
PubMed Identifier
3513311
Citation
Brown MS, Goldstein JL. A receptor-mediated pathway for cholesterol homeostasis. Science. 1986 Apr 4;232(4746):34-47. doi: 10.1126/science.3513311. No abstract available.
Results Reference
background
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Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins
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