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

NCT00001154 | Completed

• 2 other identifiers: 76005176-H-0051
• Study Type: observational
• Target: 759
• Locations: 1 country
• Sites: 1

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 injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. These lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient. 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.

Conditions

Hypolipoproteinemia; Hypercholesterolemia; Dyslipidemia; Hyperlipidemia

Keywords

Metabolism; HDL; Cholesterol; LDL; Hypoalphalipoproteinemia; Natural History

Outcome Measures

Primary Outcomes (1)

• No outcome. This is a disease discover protocol.

  Dyslipidemia

  5 years

Study Arms (1)

Patients

Subjects with new and undefined dyslipidemia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dsylipidemia

You may qualify if:

• Subjects with new and undefined dyslipidemia-particularly familial disorders with extreme phenotypes.
• Healthy normal volunteers - (18 years old or older) controls to investigate the formation of HDL for prebeta HDL.
• Euthyroid.

You may not qualify if:

• Healthy control volunteers are initially screened for secondary causes of hyperlipidemia and are excluded if they have any clinically significant laboratory abnormality (i.e., liver disease, disease, kidney disease, endocrine disease,), chronic medical problems (i.e., hypertension, migraines, inflammatory bowel, hepatitis, HIV) or require any chronic medications (i.e., acne, asthma).
• The healthy control volunteers weight must fall within the current guidelines for ideal body weight.
• Pregnant women.
• Unwilling to follow metabolic diet.
• Allergic to iodine.
• Unable to sign consent form.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hypolipoproteinemias; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Hypoalphalipoproteinemias

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert D Shamburek, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 3, 1976
• Last Updated: March 6, 2026

Record last verified: 2025-06-23

Locations

US (1)