Clinical trial NCT00942110: Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
Official title: Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Postprandial glucose, lipid metabolism
humoral factors
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin
timeFrame: baseline and 3 months after CPAP
Secondary outcomes:
measure: respiratory events (ie. apnea-hypopnea index)
timeFrame: baseline and 3 months after CPAP
measure: inflammatory biomarkers (ie. IL-6, CRP)
timeFrame: baseline and 3 months after CPAP
measure: quality of life
timeFrame: baseline and 3 months after CPAP
measure: sleep quality
timeFrame: baseline and 3 months after CPAP
measure: sympathetic activity in urine
timeFrame: baseline and 3 months after CPAP
measure: appetite
timeFrame: baseline and 3 months after CPAP
measure: endothelial function
timeFrame: baseline and 3months after CPAP
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Kazuo Chin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University, Graduate School of Medicine
name: Yuichi Chihara, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: