Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073775
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2003-12-08
Brief Title:
Epidemiology of Stress and the Metabolic Syndrome
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Epidemiology of Stress and the Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To examine the effects of psychological stress on the metabolic syndrome
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 n3075 mean age74 years 52female 42 African American and the InChianti study n1453 mean age69 years 56female 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 andor its physiological consequences either by pharmacological treatment or behavioral intervention could reduce incidence of the metabolic syndrome in the older general population
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 n3075 mean age74 years 52female 42 African American and the InChianti study n1453 mean age69 years 56female 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 andor its physiological consequences either by pharmacological treatment or behavioral intervention could reduce incidence of the metabolic syndrome in the older general population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072972 | NIH | None | httpsreporternihgovquickSearchR01HL072972 |