Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
| Tracking Information | |||||
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| First Received Date ICMJE | December 16, 2004 | ||||
| Last Updated Date | October 31, 2005 | ||||
| Start Date ICMJE | January 1997 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00099567 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline | ||||
| Official Title ICMJE | Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline | ||||
| Brief Summary | The purpose of this study is to determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation. |
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| Detailed Description | The metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin resistance. This study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood. This 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC) study conducted during the same period. Participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Allocation: Random Sample Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Cognitive Decline | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2632 | ||||
| Completion Date | December 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 70 Years to 79 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00099567 | ||||
| Other Study ID Numbers ICMJE | IA0066, 1N01AG062106, 1R01AG021918 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | December 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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