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Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

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ClinicalTrials.gov Identifier: NCT00099567
Recruitment Status : Completed
First Posted : December 17, 2004
Last Update Posted : November 1, 2005
Paul Beeson Faculty Scholars Program
University of California, San Francisco
Information provided by:
National Institute on Aging (NIA)

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.

Condition or disease
Cognitive Decline

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 Type : Observational
Estimated Enrollment : 2632 participants
Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
Study Start Date : January 1997
Estimated Study Completion Date : December 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 79 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099567

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
Principal Investigator: Kristine Yaffe, MD University of California, San Francisco

ClinicalTrials.gov Identifier: NCT00099567     History of Changes
Other Study ID Numbers: IA0066
1R01AG021918 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2004    Key Record Dates
Last Update Posted: November 1, 2005
Last Verified: December 2004

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Cognitive Dysfunction
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders