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Completed

NCT Number: NCT00942110

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

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyoto University Graduate School of Medicine

Kyoto, 6068507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP Treatment

Device

maintains upper airway patency and minimizes the obstructive events

Other names: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)

Primary outcomes

  1. postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin

    Time frame: baseline and 3 months after CPAP

Secondary outcomes

  1. respiratory events (ie. apnea-hypopnea index)

    Time frame: baseline and 3 months after CPAP

  2. inflammatory biomarkers (ie. IL-6, CRP)

    Time frame: baseline and 3 months after CPAP

  3. quality of life

    Time frame: baseline and 3 months after CPAP

  4. sleep quality

    Time frame: baseline and 3 months after CPAP

  5. sympathetic activity in urine

    Time frame: baseline and 3 months after CPAP

  6. appetite

    Time frame: baseline and 3 months after CPAP

  7. endothelial function

    Time frame: baseline and 3months after CPAP

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Official study title

Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 20, 2009
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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