|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | January 24, 2009 | ||||||||
| Start Date ICMJE | March 1976 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Level of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). | ||||||||
| Change History | Complete list of historical versions of study NCT00001154 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
The Hamilton Psychiatric Rating Scale for Anxiety (HAMA) and the Clinical Global Impression (CGI) severity scores. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins | ||||||||
| Official Title ICMJE | Lipoprotein Metabolism in Normal Volunteers and Hyperlipoproteinemic Patients | ||||||||
| 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. |
||||||||
| Detailed Description | 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. |
||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 900 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
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. |
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001154 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 760051, 76-H-0051 | ||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | January 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
