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Epidemiology of Stress and the Metabolic Syndrome
This study has been completed.
First Received: December 8, 2003   Last Updated: August 20, 2008   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00073775
  Purpose

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


Condition Phase
Cardiovascular Diseases
Heart Diseases
Obesity
Hypertension
Hyperinsulinism
Insulin Resistance
Metabolic Syndrome X
N/A

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

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

Sponsors and Collaborators
Investigators
Investigator: Marco Pahor Wake Forest University
  More Information

No publications provided

Study ID Numbers: 1239
Study First Received: December 8, 2003
Last Updated: August 20, 2008
ClinicalTrials.gov Identifier: NCT00073775     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Obesity
Heart Diseases
Metabolic Syndrome X
Metabolic Diseases
Vascular Diseases
Stress
Overweight
Abdominal Obesity Metabolic Syndrome
Body Weight
Signs and Symptoms
Hyperinsulinism
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Hypertension

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

ClinicalTrials.gov processed this record on July 02, 2009