Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

Official Title ^†

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.

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 Phase

Study Type ^†

Observational

Study Design ^†

Natural History, Longitudinal, Random Sample, Prospective Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Cognitive Decline

Intervention ^†

MEDLINE PMIDs

15536110, 12847160, 11031212

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

2632

Start Date ^†

January 1997

Completion Date

December 2002

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

Gender

Both

Ages

70 Years to 79 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00099567

Organization ID

IA0066

Secondary IDs ^††

1N01AG062106, 1R01AG021918

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

Paul Beeson Faculty Scholars Program
University of California, San Francisco

Investigators ^†

Principal Investigator:

Kristine Yaffe, MD

University of California, San Francisco

Information Provided By

National Institute on Aging (NIA)

Verification Date

December 2004

First Received Date ^†

December 16, 2004

Last Updated Date

October 31, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.