Obstructive Sleep ApneaNCT00942110
Alterations in Postprandial Glucose and Lipid Metabolism in Patients With Obstructive Sleep Apnea
A study testing CPAP treatment in people with Obstructive Sleep Apnea, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
The purpose of this study is to examine postprandial glucose and lipid metabolism in patients with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects treating for acute infections or malignancy.
- Subjects with severe anemia, diabetes,and renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP treatment
- Keywords
- Postprandial glucose, lipid metabolism, humoral factors
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
Also called REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)
maintains upper airway patency and minimizes the obstructive events
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Not described Receives: Device: CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin
Measured: baseline and 3 months after CPAP
Secondary outcomes (7)
respiratory events (ie. apnea-hypopnea index)
Measured: baseline and 3 months after CPAP
inflammatory biomarkers (ie. IL-6, CRP)
Measured: baseline and 3 months after CPAP
quality of life
Measured: baseline and 3 months after CPAP
sleep quality
Measured: baseline and 3 months after CPAP
sympathetic activity in urine
Measured: baseline and 3 months after CPAP
appetite
Measured: baseline and 3 months after CPAP
endothelial function
Measured: baseline and 3months after CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toru Oga, Kyoto University, Graduate School of Medicine
- Investigators
- Kazuo Chin, MD,PhD, Principal investigator, Kyoto University, Graduate School of MedicineYuichi Chihara, MD,PhD, Principal investigator, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942110
- Sponsor's protocol ID
- C-311
- Status last verified
- Mar 2012
- First submitted
- 17 Jul 2009
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Association Between Glucose, Lipid Metabolism and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00942110
- Acronym / sponsor ID
- C-311
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Postprandial glucose, lipid metabolism, humoral factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAP treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects treating for acute infections or malignancy.
- Subjects with severe anemia, diabetes,and renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP treatmentAlso: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)maintains upper airway patency and minimizes the obstructive events | Device | CPAP |
Primary outcome
postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin
Time frame: baseline and 3 months after CPAP
7 secondary outcomes
respiratory events (ie. apnea-hypopnea index)
Time frame: baseline and 3 months after CPAP
inflammatory biomarkers (ie. IL-6, CRP)
Time frame: baseline and 3 months after CPAP
quality of life
Time frame: baseline and 3 months after CPAP
sleep quality
Time frame: baseline and 3 months after CPAP
sympathetic activity in urine
Time frame: baseline and 3 months after CPAP
appetite
Time frame: baseline and 3 months after CPAP
endothelial function
Time frame: baseline and 3months after CPAP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuo Chin, MD,PhD principal investigator
Kyoto University, Graduate School of Medicine
Yuichi Chihara, MD,PhD principal investigator
Kyoto University, Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP treatment in people with Obstructive Sleep Apnea, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin (time frame: baseline and 3 months after CPAP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.