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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | April 1991 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005348 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Adipose Distribution and Atherosclerosis |
| Official Title ICMJE | |
| Brief Summary | To relate distribution of adipose tissue measured by a then new imaging technique, Magnetic Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk factors, and to more conventional measures of fat distribution such as body mass index (BMI) and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal fat to total or subcutaneous fat than age-sex-race matched controls. |
| Detailed Description | BACKGROUND: The study was ancillary to an NIH funded population-based project, the Atherosclerosis Risk in Communities Study (ARIC) that is ongoing in Forsyth County, North Carolina. DESIGN NARRATIVE: Using MRI, the investigators sought to demonstrate strong relationships between intra-abdominal fat and a number of cardiovascular disease risk factors, including history of hypertension, diabetes, cigarette smoking, family history of cardiovascular disease, plasma concentrations of triglyceride, high density lipoprotein (HDL) cholesterol, HDL2 cholesterol, apo A1, Apo B, postprandial lipid response to a fat rich meal, glucose, insulin, sex hormone binding globulin, and total and free testosterone. Certain other risk factors were less certain to show a relation to intra-abdominal fat as measured by MRI, including various hemostatic factors, as well as certain dietary factors such as consumption of alcohol, dietary fat, and cholesterol, but this research afforded an opportunity to explore these relationships. Finally, the investigators proposed to relate intra-abdominal fat to more conventional measures of fat distribution (waist/hip ratio, subscapular skinfold thickness, etc.) in an attempt to identify strong correlates of intra-abdominal fat that could be more easily measured. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | Terry JG, Hinson WH, Evans GW, Schreiner PJ, Hagaman AP, Crouse JR 3rd. Evaluation of magnetic resonance imaging for quantification of intraabdominal fat in human beings by spin-echo and inversion-recovery protocols. Am J Clin Nutr. 1995 Aug;62(2):297-301. |
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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 | March 1993 |
| 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 | NCT00005348 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4217 |
| 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 | April 2000 |
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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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