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

Healthy Clinical Trial

Official title:

Lipoprotein Metabolism in Normal Volunteers and Dyslipoproteinemic Patients (Stable Isotopes)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001226
• Other study ID #: 870207
• Secondary ID: 87-H-0207
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: December 1987
• Est. completion date: March 2002

Study information

• Verified date: March 2002
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Healthy
• Hyperlipoproteinemia
• Hyperlipoproteinemias

Locations

Country	Name	City	State
United States	National Heart, Lung and Blood Institute (NHLBI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Brown MS, Goldstein JL. A receptor-mediated pathway for cholesterol homeostasis. Science. 1986 Apr 4;232(4746):34-47. Review. — View 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. — View Citation