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Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00942110
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to examine postprandial glucose and lipid metabolism in patients with obstructive sleep apnea.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: CPAP treatment

Detailed Description:
Obstructive sleep apnea (OSA) is an increasingly prevalent condition that is characterized by repetitive upper airway obstructions. OSA has been independently associated with insulin resistance, suggesting that OSA may contribute to the development of type 2 diabetes and the metabolic syndrome. Recently, postprandial glucose and lipid have been reported as excellent predictors for mortality and cardiovascular risk. However, the association between postprandial glucose, lipid metabolism and OSA are not clear. In addition, humoral factors such as ghrelin and leptin are associated with obesity and OSA, but postprandial changes of which in patients with OSA are not well known. The aim of present study is to examine postprandial glucose and lipid metabolism, humoral factors in OSA before and after 3 months of continuous positive airway pressure (CPAP) treatment.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea
Study Start Date : September 2009
Primary Completion Date : December 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CPAP Device: CPAP treatment
maintains upper airway patency and minimizes the obstructive events
Other Name: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)


Outcome Measures

Primary Outcome Measures :
  1. postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin [ Time Frame: baseline and 3 months after CPAP ]

Secondary Outcome Measures :
  1. respiratory events (ie. apnea-hypopnea index) [ Time Frame: baseline and 3 months after CPAP ]
  2. inflammatory biomarkers (ie. IL-6, CRP) [ Time Frame: baseline and 3 months after CPAP ]
  3. quality of life [ Time Frame: baseline and 3 months after CPAP ]
  4. sleep quality [ Time Frame: baseline and 3 months after CPAP ]
  5. sympathetic activity in urine [ Time Frame: baseline and 3 months after CPAP ]
  6. appetite [ Time Frame: baseline and 3 months after CPAP ]
  7. endothelial function [ Time Frame: baseline and 3months after CPAP ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
  • Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.

Exclusion Criteria:

  • Subjects treating for acute infections or malignancy.
  • Subjects with severe anemia, diabetes,and renal failure.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942110


Locations
Japan
Kyoto University Graduate School of Medicine
Kyoto, Japan, 6068507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
Principal Investigator: Kazuo Chin, MD,PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Yuichi Chihara, MD,PhD Kyoto University, Graduate School of Medicine
More Information

Responsible Party: Toru Oga, Medical doctor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00942110     History of Changes
Other Study ID Numbers: C-311
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

Keywords provided by Toru Oga, Kyoto University, Graduate School of Medicine:
Postprandial glucose, lipid metabolism
humoral factors

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases