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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | February 1993 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005365 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Central Obesity and Disease Risk in Japanese Americans | ||||
| Official Title ICMJE | |||||
| Brief Summary | To conduct a longitudinal study of central obesity and related risk factors found to be associated with hypertension and atherosclerotic cardiovascular disease (ASCVD) in a previously-examined cross-sectional cohort of second-generation Japanese Americans and in a newly-recruited cohort of third generation Japanese Americans. |
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| Detailed Description | BACKGROUND: The study was conducted in response to a program announcment issued in 1991 on obesity and tests the hypothesis that atherosclerotic cardiovascular disease (ASCVD), hypertension, and/or non-insulin dependent diabetes mellitus (NIDDM) develop in Japanese Americans when there is a truncal pattern of weight gain (central adiposity), which is in turn accompanied by insulin resistance, hyperinsulinemia, and lipid abnormalities. This cluster of abnormalities has been called 'Syndrome X'. It is postulated that 'Syndrome X' develops in Japanese Americans in response to environmental (behavioral) factors, many of which reflect 'westernization' in this ethnic group. The research plan focuses upon the relationship between central obesity and metabolic changes and disease outcomes associated with 'Syndrome X' along with the behavioral variables that potential risk factors for the development of this cluster of abnormalities. DESIGN NARRATIVE: The cohort was re-examined for diabetes, hypertension, coronary heart, disease, peripheral vascular disease, and a number of potential coronary heart disease risk factors including medical history, health practice, social history, diet, glycosylated hemoglobin, insulin, proinsulin, c-peptide, glucose, anthrometric measurements, lipids, and computed tomography on the thorax, abdomen, and thigh. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Natural History | ||||
| 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 | January 1998 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | 45 Years to 74 Years | ||||
| 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 | NCT00005365 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 4252 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | August 2004 | ||||
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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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