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Protocol Details

Lipoprotein Metabolism in Normal Volunteers and Hyperlipoproteinemic Patients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

76-H-0051

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Cholesterol;
Apolipoproteins;
Kinetics

Recruitment Keyword(s)

None

Condition(s)

Abetalipoproteinemia;
Atherosclerosis;
Healthy;
Inborn Errors Lipid Metabolism

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.


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Citations:

Apolipoprotein E metabolism in normolipoproteinemic human subjects

Human apolipoprotein A-I isoprotein metabolism: proapoA-I conversion to mature apoA-I

Abnormal in vivo metabolism of apolipoprotein E(4) in humans

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert D. Shamburek, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10 RM 8N202
10 CENTER DR
BETHESDA MD 20814
(301) 496-3460
bobs@mail.nih.gov

Robert D. Shamburek, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10 RM 8N202
10 CENTER DR
BETHESDA MD 20814
(301) 496-3460
bobs@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001154

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