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

Tracking Information
First Submitted Date ICMJE	July 17, 2009
First Posted Date ICMJE	July 20, 2009
Last Update Posted Date	March 6, 2012
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 19, 2012)	postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin [ Time Frame: baseline and 3 months after CPAP ]
Original Primary Outcome Measures ICMJE; (submitted: July 17, 2009)	postprandial glucose, cholesterol, triglyceride, grelin, leptin [ Time Frame: 3 months ]
Change History	Complete list of historical versions of study NCT00942110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 19, 2012)	respiratory events (ie. apnea-hypopnea index) [ Time Frame: baseline and 3 months after CPAP ]; inflammatory biomarkers (ie. IL-6, CRP) [ Time Frame: baseline and 3 months after CPAP ]; quality of life [ Time Frame: baseline and 3 months after CPAP ]; sleep quality [ Time Frame: baseline and 3 months after CPAP ]; sympathetic activity in urine [ Time Frame: baseline and 3 months after CPAP ]; appetite [ Time Frame: baseline and 3 months after CPAP ]; endothelial function [ Time Frame: baseline and 3months after CPAP ]
Original Secondary Outcome Measures ICMJE; (submitted: July 17, 2009)	respiratory events (ie. apnea-hypopnea index), inflammatory biomarkers (ie. IL-6, CRP), quality of life, sleep quality, physical status, appetite et al. [ Time Frame: 3 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
Official Title ICMJE	Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Obstructive Sleep Apnea
Intervention ICMJE	Device: CPAP treatment; maintains upper airway patency and minimizes the obstructive events; Other Name: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)
Study Arms	Experimental: CPAP; Intervention: Device: CPAP treatment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 5, 2012)	58
Original Estimated Enrollment ICMJE; (submitted: July 17, 2009)	30
Actual Study Completion Date	March 2012
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Japan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00942110
Other Study ID Numbers ICMJE	C-311
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Toru Oga, Kyoto University, Graduate School of Medicine
Study Sponsor ICMJE	Kyoto University, Graduate School of Medicine
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Kazuo Chin, MD,PhD Kyoto University, Graduate School of Medicine Principal Investigator: Yuichi Chihara, MD,PhD Kyoto University, Graduate School of Medicine
PRS Account	Kyoto University, Graduate School of Medicine
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP