- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00099567
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Tennessee
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Memphis, Tennessee, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 70 to 79
- White or Black
- Community-dwelling in Memphis, TN or Pittsburgh, PA vicinity
- Well-functioning (no difficulty in walking a quarter of a mile or going up 10 steps without resting)
Exclusion Criteria:
- Any difficulty with activities of daily living
- Clinical dementia
- Inability to communicate with interviewer
- Intention of moving out of vicinity in the next year
- Active treatment for cancer in the previous 3 years
- Participation in a trial involving a lifestyle intervention
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Kristine Yaffe, MD, University of California, San Francisco
Publications and helpful links
General Publications
- Kalmijn S, Foley D, White L, Burchfiel CM, Curb JD, Petrovitch H, Ross GW, Havlik RJ, Launer LJ. Metabolic cardiovascular syndrome and risk of dementia in Japanese-American elderly men. The Honolulu-Asia aging study. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2255-60. doi: 10.1161/01.atv.20.10.2255.
- Yaffe K, Lindquist K, Penninx BW, Simonsick EM, Pahor M, Kritchevsky S, Launer L, Kuller L, Rubin S, Harris T. Inflammatory markers and cognition in well-functioning African-American and white elders. Neurology. 2003 Jul 8;61(1):76-80. doi: 10.1212/01.wnl.0000073620.42047.d7.
- Yaffe K, Kanaya A, Lindquist K, Simonsick EM, Harris T, Shorr RI, Tylavsky FA, Newman AB. The metabolic syndrome, inflammation, and risk of cognitive decline. JAMA. 2004 Nov 10;292(18):2237-42. doi: 10.1001/jama.292.18.2237.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IA0066
- 1N01AG062106
- 1R01AG021918 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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