Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442624
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2007-03-01
Brief Title:
Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism
Status:
COMPLETED
Status Verified Date:
2012-03
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:
We aim to assess the influence of chronic insomnia on the neuroendocrine regulation of the glucose and lipid metabolism to more clearly define the metabolic derangements associated with chronic insomnia and to prove that chronic insomnia is associated with increased levels of stress hormones cytokines and impaired insulin sensitivity
Detailed Description:
Sleep fragmentation has previously been shown to result in activation of the stress axis as indicated by enhanced cortisol and catecholamine release and a proinflammatory state mirrored by increased concentrations of proinflammatory cytokines such as IL-6 and TNFa Therefore sleep deprivation is associated with a similar pattern of endocrine and proinflammatory alterations that may promote the insulin resistant state Thus it is of paramount interest to clearly define the metabolic alterations in patients with primary insomnia
Patients with with suspected primary insomnia will be recruited from the sleep clinic at the University Hospital Basel and by newspaper ads Primary insomnia will be diagnosed by a polysomnographic study and the exclusion of secondary causes such as depression sleep apnea and restless legs syndrome Eligible patients will be admitted to the CRC for metabolic studies including baseline blood samples for the measurement of hormones cytokines and adipokines a euglycemic-hyperinsulinemic clamp study for the assessment of glucose turnover and insulin sensitivity and in vivo NMR studies to determine intrahepatic and intramyocellular lipid content
The data obtained in insomnic patients will be compared to those of a control group matched for age sex BMI menopausal status and physical activity selected from the general population
Patients with with suspected primary insomnia will be recruited from the sleep clinic at the University Hospital Basel and by newspaper ads Primary insomnia will be diagnosed by a polysomnographic study and the exclusion of secondary causes such as depression sleep apnea and restless legs syndrome Eligible patients will be admitted to the CRC for metabolic studies including baseline blood samples for the measurement of hormones cytokines and adipokines a euglycemic-hyperinsulinemic clamp study for the assessment of glucose turnover and insulin sensitivity and in vivo NMR studies to determine intrahepatic and intramyocellular lipid content
The data obtained in insomnic patients will be compared to those of a control group matched for age sex BMI menopausal status and physical activity selected from the 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