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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942110
• Other study ID #: C-311
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: March 5, 2012
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP treatment
maintains upper airway patency and minimizes the obstructive events

Locations

Country	Name	City	State
Japan	Kyoto University Graduate School of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin		baseline and 3 months after CPAP	No
Secondary	respiratory events (ie. apnea-hypopnea index)		baseline and 3 months after CPAP	No
Secondary	inflammatory biomarkers (ie. IL-6, CRP)		baseline and 3 months after CPAP	No
Secondary	quality of life		baseline and 3 months after CPAP	No
Secondary	sleep quality		baseline and 3 months after CPAP	No
Secondary	sympathetic activity in urine		baseline and 3 months after CPAP	No
Secondary	appetite		baseline and 3 months after CPAP	No
Secondary	endothelial function		baseline and 3months after CPAP	No