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Influence of nCPAP on Metabolic Consequences Associated With OSAS

Primary Purpose

Obstructive Sleep Apnea Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
nasal continuous positive airway pressure
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea Syndrome focused on measuring Sleep apnea,, adiponectin ,, HPA axis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged from 18 to 65 years
  • Body mass index between 35-60 who were submitted to polysomnography

Exclusion Criteria:

  • History of smoking
  • Sleep apnea treatment
  • Cardiovascular disease
  • Malignancies tumor
  • Thyroid disorders
  • Depression
  • Subjects with known diabetes mellitus on medications
  • Chronic renal or hepatic failure
  • On hormonal replacement therapy, as well as use of medication that could potentially affect steroid hormone or cytokines secretion (alcohol, psychotropics, steroids, sympathomimetics, beta-blockers).

Sites / Locations

  • Universidade Federal de Sao Paulo

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

10 patients with severe OSAS (Apnea Hypopnea Index of more than 30 events per hour of sleep) were treated with nCPAP for three months and all mentioned measurements above were repeated.

Outcomes

Primary Outcome Measures

To explore the interactive mechanisms of HPA axis, sympathetic nervous system activation, inflammatory cytokines, insulin resistance and hypertension in patients with and without sleep apnea, excluding the interference of the degree of fat accumulation.

Secondary Outcome Measures

To evaluate low-dose dexamethasone-induced cortisol suppression and circadian rhythm of cortisol secretion in severe obese patients with sleep apnea in response to treatment with continuous positive airway pressure.

Full Information

First Posted
February 14, 2007
Last Updated
November 19, 2007
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00435643
Brief Title
Influence of nCPAP on Metabolic Consequences Associated With OSAS
Official Title
Improvement in Hypothalamic-Pituitary-Adrenal Axis Function After Continuous Positive Airway Pressure Therapy in Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 risk.These 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 0.25 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 (p<0.05) and salivary cortisol suppression pos DEX (p<0.05) were lower, while heart rate (p<0.05) and TNF-alpha levels (p<0.05) were higher compared with obese controls. After nCPAP therapy, patients showed a reduction in heart rate (p=0.036) and a higher cortisol suppression after dexamethasone (p=0.001) and there were no differences in insulin resistance (HOMA p=0.139), arterial blood pressure (p=0.183) and adipokines compared with baseline. Cortisol suppression was positively correlated with the improvement of apnea hypopnea index while on nCPAP therapy (r= 0.799, p=0.010). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Obesity
Keywords
Sleep apnea,, adiponectin ,, HPA axis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
10 patients with severe OSAS (Apnea Hypopnea Index of more than 30 events per hour of sleep) were treated with nCPAP for three months and all mentioned measurements above were repeated.
Intervention Type
Procedure
Intervention Name(s)
nasal continuous positive airway pressure
Intervention Description
After an average interval of three months, 10 patients with severe OSAS (AHI of more than 30 events per hour of sleep) treated with a mean nCPAP pressure of 11.2 ± 0.7 cm of H2O were reassessed and all mentioned measurements above were repeated
Primary Outcome Measure Information:
Title
To explore the interactive mechanisms of HPA axis, sympathetic nervous system activation, inflammatory cytokines, insulin resistance and hypertension in patients with and without sleep apnea, excluding the interference of the degree of fat accumulation.
Time Frame
one day
Secondary Outcome Measure Information:
Title
To evaluate low-dose dexamethasone-induced cortisol suppression and circadian rhythm of cortisol secretion in severe obese patients with sleep apnea in response to treatment with continuous positive airway pressure.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged from 18 to 65 years Body mass index between 35-60 who were submitted to polysomnography Exclusion Criteria: History of smoking Sleep apnea treatment Cardiovascular disease Malignancies tumor Thyroid disorders Depression Subjects with known diabetes mellitus on medications Chronic renal or hepatic failure On hormonal replacement therapy, as well as use of medication that could potentially affect steroid hormone or cytokines secretion (alcohol, psychotropics, steroids, sympathomimetics, beta-blockers).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gláucia Carneiro, MD
Organizational Affiliation
UNIFESP-EPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15728214
Citation
Buckley TM, Schatzberg AF. On the interactions of the hypothalamic-pituitary-adrenal (HPA) axis and sleep: normal HPA axis activity and circadian rhythm, exemplary sleep disorders. J Clin Endocrinol Metab. 2005 May;90(5):3106-14. doi: 10.1210/jc.2004-1056. Epub 2005 Feb 22.
Results Reference
background
PubMed Identifier
14678286
Citation
Lanfranco F, Gianotti L, Pivetti S, Navone F, Rossetto R, Tassone F, Gai V, Ghigo E, Maccario M. Obese patients with obstructive sleep apnoea syndrome show a peculiar alteration of the corticotroph but not of the thyrotroph and lactotroph function. Clin Endocrinol (Oxf). 2004 Jan;60(1):41-8. doi: 10.1111/j.1365-2265.2004.01938.x.
Results Reference
background
PubMed Identifier
17033258
Citation
Masserini B, Morpurgo PS, Donadio F, Baldessari C, Bossi R, Beck-Peccoz P, Orsi E. Reduced levels of adiponectin in sleep apnea syndrome. J Endocrinol Invest. 2006 Sep;29(8):700-5. doi: 10.1007/BF03344179.
Results Reference
background
PubMed Identifier
15761179
Citation
Wolk R, Svatikova A, Nelson CA, Gami AS, Govender K, Winnicki M, Somers VK. Plasma levels of adiponectin, a novel adipocyte-derived hormone, in sleep apnea. Obes Res. 2005 Jan;13(1):186-90. doi: 10.1038/oby.2005.24.
Results Reference
background
PubMed Identifier
15897474
Citation
Degawa-Yamauchi M, Moss KA, Bovenkerk JE, Shankar SS, Morrison CL, Lelliott CJ, Vidal-Puig A, Jones R, Considine RV. Regulation of adiponectin expression in human adipocytes: effects of adiposity, glucocorticoids, and tumor necrosis factor alpha. Obes Res. 2005 Apr;13(4):662-9. doi: 10.1038/oby.2005.74.
Results Reference
background
PubMed Identifier
21626286
Citation
Carneiro G, Florio RT, Zanella MT, Pradella-Hallinan M, Ribeiro-Filho FF, Tufik S, Togeiro SM. Is mandatory screening for obstructive sleep apnea with polysomnography in all severely obese patients indicated? Sleep Breath. 2012 Mar;16(1):163-8. doi: 10.1007/s11325-010-0468-7. Epub 2011 May 29.
Results Reference
derived

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Influence of nCPAP on Metabolic Consequences Associated With OSAS

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