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Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
This study has been completed.
Sponsor:
Kyoto University, Graduate School of Medicine
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00942110
First received: July 17, 2009
Last updated: March 5, 2012
Last verified: March 2012
| Tracking Information | |||||||
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| First Received Date ICMJE | July 17, 2009 | ||||||
| Last Updated Date | March 5, 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 |
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| 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: Open Label Primary Purpose: Treatment |
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| 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) |
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| Study Arms | Experimental: CPAP
Intervention: Device: CPAP treatment |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Enrollment ICMJE | 58 | ||||||
| Completion Date | March 2012 | ||||||
| Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Senior) | ||||||
| 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 | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | 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 |
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| PRS Account | Kyoto University, Graduate School of Medicine | ||||||
| Verification Date | March 2012 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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