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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | September 1993 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005709 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Lipoprotein Metabolism in Hypertensive African-Americans |
| Official Title ICMJE | |
| Brief Summary | To study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in African American males and females. The study was part of a Collaborative Project on Minority Health which investigated the mechanisms by which insulin contributes to cardiovascular disease. |
| Detailed Description | BACKGROUND: The study was part of the initiative "Collaborative Projects (R01s) on Minority Health". The concept for the initiative was developed by the NHLBI staff after the 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The initiative was approved at the September 1992 National Heart, Lung, and Blood Advisory Council and released in October 1992. Julian Marsh was one of three investigators in a collaborative program with Bonita Falkner as Program Coordinator. DESIGN NARRATIVE: In a sub-set of subjects with either high or low plasma insulin levels after a glucose challenge (insulin sensitive or insulin resistant), the investigators determined the fractional and absolute synthesis and catabolic rates of apolipoproteins B and A-I, the dominant lipoproteins of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL). They used stable isotopes and multicompartmental kinetic analysis following an oral bolus dose of deuteroleucine. They hypothesized that in hypertensive African Americans with hyperinsulinemia, more of the smaller Very Low Density (VLDL) particles are secreted and converted to LDL. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | August 1998 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005709 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4918 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | June 2001 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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