Epidemiology of Stress and the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00073775
First received: December 8, 2003
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

To examine the effects of psychological stress on the metabolic syndrome.


Condition
Cardiovascular Diseases
Heart Diseases
Obesity
Hypertension
Hyperinsulinism
Insulin Resistance
Metabolic Syndrome X

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Stress and the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • There is no primary outcome [ Time Frame: There is no time frame ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA, blood


Enrollment: 3075
Study Start Date: September 2003
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The metabolic syndrome identifies the clustering of lipid abnormalities, hypertension, hyperglycemia and abdominal obesity. It is a common and strong contributor to heart disease and diabetes and disproportionably affects older persons. Animal and small clinical studies have suggested that psychosocial stress is a risk factor for the metabolic syndrome. Underlying mechanisms may be through activation of the hypothalamopituitary-adrenal (HPA) axis causing hypercortisolemia, and, partly in turn, elevated inflammation and decreased sex hormone levels. However, longitudinal data showing that psychosocial stress indeed contributes to the onset and sequelae of the metabolic syndrome in the population at large, are lacking.

DESIGN NARRATIVE:

The primary objectives are to conduct data-analyses and biological sample analyses to examine the effect of psychosocial stress, as indicated by mood problems (depressive symptoms) and stressful social circumstances (poverty, negative life events, occupational stress, lack of emotional support), on the onset and sequelae of the metabolic syndrome. Secondary objectives are to examine underlying biological mechanisms in the effect of psychosocial stress on the metabolic syndrome. The investigators will use available data from two ongoing longitudinal community-based studies among older persons: the Health Aging and Body Composition (Health ABC) study (n=3,075, mean age=74 years, 52%=female, 42% African American) and the InChianti study (n=1,453, mean age=69 years, 56%=female). In both studies psychosocial stress and the metabolic syndrome are well defined, longitudinal data on sequelae (CVD events and diabetes onset) and onset of the metabolic syndrome are available, and potentially underlying biological variables were, or will be, assessed including 24-h urinary cortisol, serum sex steroid hormones (estradiol, testosterone, SHBG, DHEAS) and inflammatory markers (IL-6, IL-10, TNF-alpha, CRP, and various soluble cytokine receptors). The results of this study will help in designing future intervention trials that evaluate whether reducing stress and/or its physiological consequences, either by pharmacological treatment or behavioral intervention, could reduce incidence of the metabolic syndrome in the older general population.

  Eligibility

Ages Eligible for Study:   70 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Older persons

Criteria

Age >70 years Community swelling

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00073775

Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Marco Pahor University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00073775     History of Changes
Other Study ID Numbers: 1239, R01HL072972
Study First Received: December 8, 2003
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperinsulinism
Cardiovascular Diseases
Heart Diseases
Hypertension
Insulin Resistance
Obesity
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014