Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

NCT ID: NCT00099567

Last Updated: 2005-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2632 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Study Completion Date

2002-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Decline

Keywords

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Metabolic Syndrome Alzheimer's Disease Cognitive Impairment Inflammation

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paul Beeson Faculty Scholars Program

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Kristine Yaffe, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Pittsburgh, Pennsylvania, United States

Site Status

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12847160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11031212 (View on PubMed)

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.

Reference Type RESULT
PMID: 15536110 (View on PubMed)

Other Identifiers

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1N01AG062106

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AG021918

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0066

Identifier Type: -

Identifier Source: org_study_id