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Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

This study has been completed.
Sponsor:
Collaborators:
Paul Beeson Faculty Scholars Program
University of California, San Francisco
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00099567
First received: December 16, 2004
Last updated: October 31, 2005
Last verified: December 2004
History of Changes
  Purpose

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.


Condition
Cognitive Decline

Study Type: Observational
Study Design: Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 2632
Study Start Date: January 1997
Estimated Study Completion Date: December 2002
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

Ages Eligible for Study:   70 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099567

Locations
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
National Institute on Aging (NIA)
Paul Beeson Faculty Scholars Program
University of California, San Francisco
Investigators
Principal Investigator: Kristine Yaffe, MD University of California, San Francisco
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00099567     History of Changes
Other Study ID Numbers: IA0066, 1N01AG062106, 1R01AG021918
Study First Received: December 16, 2004
Last Updated: October 31, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Metabolic Syndrome
Alzheimer's Disease
Cognitive Impairment
Inflammation

Additional relevant MeSH terms:
Inflammation
Cognition Disorders
Metabolic Syndrome X
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013