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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001154 |
Purpose
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.
| Condition |
|---|
|
Abetalipoproteinemia Atherosclerosis Healthy Inborn Errors Lipid Metabolism |
| Study Type: | Observational |
| Official Title: | Lipoprotein Metabolism in Normal Volunteers and Hyperlipoproteinemic Patients |
| Estimated Enrollment: | 900 |
| Study Start Date: | March 1976 |
We propose to investigate human in vivo lipoprotein metabolism using either radiolabeled apolipoproteins or nonradioactive isotopically labeled amino acids. Paired kinetic studies using dual-labeled iodinated lipoproteins and apolipoproteins are performed in normal volunteers and dyslipidemic patients under controlled metabolic conditions. Additional kinetic studies are proposed in order to quantitate the kinetics of the metabolism of apolipoproteins utilizing nonradioactive isotope labeled amino acids. Studies are designed to formulate metabolic pathways in patients with defined genetic disorders of lipid metabolism as well as in healthy volunteers to provide original insights into normal and pathologic metabolic pathways. All kinetic data is computer analyzed to provide quantitative data and facilitate direct comparison of multiple studies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Subjects with dyslipidemia-particularly familial disorders.
Healthy normal volunteers - (18 years old or older).
Euthyroid.
EXCLUSION CRITERIA:
Healthy volunteers will be 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 normal 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.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 760051, 76-H-0051 |
| Study First Received: | November 3, 1999 |
| Last Updated: | January 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00001154 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cholesterol Apolipoproteins Kinetics |
|
Atherosclerosis Lipid Metabolism, Inborn Errors Arterial Occlusive Diseases Metabolic Diseases Vascular Diseases Hypolipoproteinemias Arteriosclerosis |
Abetalipoproteinemia Hypobetalipoproteinemias Metabolism, Inborn Errors Genetic Diseases, Inborn Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders |
