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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00942110

First Posted: July 20, 2009

Last Update Posted: March 6, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Toru Oga, Kyoto University, Graduate School of Medicine

Tracking Information

First Submitted Date ^ICMJE

July 17, 2009

First Posted Date ^ICMJE

July 20, 2009

Last Update Posted Date

March 6, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

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

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 Provided

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

Enrollment ^ICMJE

Completion Date

March 2012

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, Senior)

Accepts Healthy Volunteers

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

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