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

This study has been completed.
Sponsor:
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
History of Changes

July 17, 2009
March 5, 2012
September 2009
December 2011   (final data collection date for primary outcome measure)
postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
postprandial glucose, cholesterol, triglyceride, grelin, leptin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942110 on ClinicalTrials.gov Archive Site
  • respiratory events (ie. apnea-hypopnea index) [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
  • inflammatory biomarkers (ie. IL-6, CRP) [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
  • sleep quality [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
  • sympathetic activity in urine [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
  • appetite [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]
  • endothelial function [ Time Frame: baseline and 3months after CPAP ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea

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

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
Device: CPAP treatment
maintains upper airway patency and minimizes the obstructive events
Other Name: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)
Experimental: CPAP
Intervention: Device: CPAP treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
March 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00942110
C-311
Yes
Toru Oga, Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
Not Provided
Principal Investigator: Kazuo Chin, MD,PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Yuichi Chihara, MD,PhD Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP