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
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea
Device: CPAP treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin [ Time Frame: baseline and 3 months after CPAP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 58
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP Device: CPAP treatment
maintains upper airway patency and minimizes the obstructive events
Other Name: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942110

Locations
Japan
Kyoto University Graduate School of Medicine
Kyoto, Japan, 6068507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
Principal Investigator: Kazuo Chin, MD,PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Yuichi Chihara, MD,PhD Kyoto University, Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Toru Oga, Medical doctor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00942110     History of Changes
Other Study ID Numbers: C-311
Study First Received: July 17, 2009
Last Updated: March 5, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University, Graduate School of Medicine:
Postprandial glucose, lipid metabolism
humoral factors

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014