Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435643
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2007-02-14
Brief Title:
Influence of nCPAP on Metabolic Consequences Associated With OSAS
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Improvement in Hypothalamic-Pituitary-Adrenal Axis Function After Continuous Positive Airway Pressure Therapy in Obstructive Sleep Apnea Syndrome
Status:
COMPLETED
Status Verified Date:
2007-11
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:
Context Obstructive sleep apnea syndrome OSAS is associated with cardiovascular morbidity Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that may predispose to high cardiovascular riskThese risks can rapidly be reduced by effective nasal continuous positive airway pressure nCPAP therapy Objective To evaluate hypothalamic pituitary adrenal axis insulin resistance blood pressure values and adipokines in severe obese patients with and without OSAS and to determine if continuous positive airway pressure therapy nCPAP influenced responses
Detailed Description:
Background There is evidence that obstructive sleep apnea syndrome OSAS increases the risk of cardiovascular events Sympathetic nervous system and hypothalamic-pituitary-adrenal HPA axis activation may be the mechanism of this relationship We evaluate HPA axis and metabolic consequences in obese patients with and without OSAS and we determine if continuous positive airway pressure therapy nCPAP influenced responses
Methods Plasma inflammatory cytokines insulin resistance index 24-hour ambulatory blood pressure monitoring and overnight cortisol suppression test with 025 mg of dexamethasone were performed in 22 severe obese patients with OSAS and 23 obese controls Ten patients with severe apnea were re-evaluated three months after nCPAP therapy
Results Body mass index abdominal circumference blood pressure levels and insulin resistance indexes of OSAS patients and obese controls were very similar In OSAS patients adiponectin p005 and salivary cortisol suppression pos DEX p005 were lower while heart rate p005 and TNF-alpha levels p005 were higher compared with obese controls After nCPAP therapy patients showed a reduction in heart rate p0036 and a higher cortisol suppression after dexamethasone p0001 and there were no differences in insulin resistance HOMA p0139 arterial blood pressure p0183 and adipokines compared with baseline Cortisol suppression was positively correlated with the improvement of apnea hypopnea index while on nCPAP therapy r 0799 p0010
Conclusions Patients with OSAS present nocturnal hypercortisolism hyperactivity of sympathetic central nervous system a higher degree of inflammation and hypoadiponectinemia independent of the body mass index Furthermore hyperactivity of HPA axis and sympathetic nervous system are recovered by nCPAP
Methods Plasma inflammatory cytokines insulin resistance index 24-hour ambulatory blood pressure monitoring and overnight cortisol suppression test with 025 mg of dexamethasone were performed in 22 severe obese patients with OSAS and 23 obese controls Ten patients with severe apnea were re-evaluated three months after nCPAP therapy
Results Body mass index abdominal circumference blood pressure levels and insulin resistance indexes of OSAS patients and obese controls were very similar In OSAS patients adiponectin p005 and salivary cortisol suppression pos DEX p005 were lower while heart rate p005 and TNF-alpha levels p005 were higher compared with obese controls After nCPAP therapy patients showed a reduction in heart rate p0036 and a higher cortisol suppression after dexamethasone p0001 and there were no differences in insulin resistance HOMA p0139 arterial blood pressure p0183 and adipokines compared with baseline Cortisol suppression was positively correlated with the improvement of apnea hypopnea index while on nCPAP therapy r 0799 p0010
Conclusions Patients with OSAS present nocturnal hypercortisolism hyperactivity of sympathetic central nervous system a higher degree of inflammation and hypoadiponectinemia independent of the body mass index Furthermore hyperactivity of HPA axis and sympathetic nervous system are recovered by nCPAP
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