Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

Cognitive Decline Clinical Trial

Official title:

Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099567
• Other study ID #: IA0066
• Secondary ID: 1N01AG0621061R01
• Status: Completed
• Phase: N/A
• First received: December 16, 2004
• Last updated: October 31, 2005
• Start date: January 1997
• Est. completion date: December 2002

Study information

• Verified date: December 2004
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2632
• Est. completion date: December 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years to 79 Years

Eligibility

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 Design

Allocation: Random Sample, Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline
• Inflammation
• Metabolic Syndrome X

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Paul Beeson Faculty Scholars Program, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation