Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00073775 |
| Other study ID # |
1239 |
| Secondary ID |
R01HL072972 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 8, 2003 |
| Last updated |
August 8, 2013 |
| Start date |
September 2003 |
| Est. completion date |
August 2008 |
Study information
| Verified date |
August 2013 |
| Source |
University of Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial Summary
To examine the effects of psychological stress on the metabolic syndrome.
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.
