Clinical trial NCT00099567: Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
Official title: Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Decline
Keywords: Metabolic Syndrome
Alzheimer's Disease
Cognitive Impairment
Inflammation
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: Paul Beeson Faculty Scholars Program
name: University of California, San Francisco
First posted: 2004-12-17
Enrollment: 2632
Sex: ALL
Minimum age (years): 70
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
Study officials:
affiliation: University of California, San Francisco
name: Kristine Yaffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.