Back to resultsAlterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CPAP treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Postprandial glucose, lipid metabolism, humoral factors
Eligibility 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.
Sites / Locations
- Kyoto University Graduate School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CPAP
Arm Description
Outcomes
Primary Outcome Measures
postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin
Secondary Outcome Measures
respiratory events (ie. apnea-hypopnea index)
inflammatory biomarkers (ie. IL-6, CRP)
quality of life
sleep quality
sympathetic activity in urine
appetite
endothelial function
Full Information
NCT ID
NCT00942110
First Posted
July 17, 2009
Last Updated
March 5, 2012
Sponsor
Kyoto University, Graduate School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00942110
Brief Title
Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
Official Title
Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University, Graduate School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine postprandial glucose and lipid metabolism in patients with obstructive sleep apnea.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Postprandial glucose, lipid metabolism, humoral factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CPAP treatment
Other Intervention Name(s)
REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)
Intervention Description
maintains upper airway patency and minimizes the obstructive events
Primary Outcome Measure Information:
Title
postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin
Time Frame
baseline and 3 months after CPAP
Secondary Outcome Measure Information:
Title
respiratory events (ie. apnea-hypopnea index)
Time Frame
baseline and 3 months after CPAP
Title
inflammatory biomarkers (ie. IL-6, CRP)
Time Frame
baseline and 3 months after CPAP
Title
quality of life
Time Frame
baseline and 3 months after CPAP
Title
sleep quality
Time Frame
baseline and 3 months after CPAP
Title
sympathetic activity in urine
Time Frame
baseline and 3 months after CPAP
Title
appetite
Time Frame
baseline and 3 months after CPAP
Title
endothelial function
Time Frame
baseline and 3months after CPAP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuo Chin, MD,PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuichi Chihara, MD,PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Graduate School of Medicine
City
Kyoto
ZIP/Postal Code
6068507
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
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