Obstructive Sleep ApneaNCT01173432
Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction
A study testing continuous positive airway pressure in people with Obstructive Sleep Apnea and Insulin Resistance, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose metabolism have been described, and it is suggested to play an important role in the pathogenesis of metabolic syndrome.We hypothesize that… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2008to Dec 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between 18 - 65 years old
- Able to understand and give informed written consent
Who cannot join
- BMI > 35 kg/m2, and features of obesity hypoventilation syndrome
- known diabetes mellitus or hyperlipidemia on treatment
- known cardiovascular disease except hypertension stable on treatment
- unstable medical illness
- need for starting treatment for OSA or other medical conditions immediately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of the Effect of Continuous Positive Airway Pressure on Adipocyte Fatty Acid Binding Protein and Other Metabolic Markers in Obstructive Sleep Apnea
Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose metabolism have been described, and it is suggested to play an important role in the pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our group has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is present in the blood stream .The levels of A-FABP correlated with various metabolic variates in the metabolic syndrome. Furthermore, we have obtained novel data in men with a range of sleep disordered breathing showed that the duration of oxygen desaturation correlated with circulating levels of A-FABP, independent of age and waist/body mass index. The current proposal aims to pursue this finding and further explore the role of A-FABP in the association of OSA and metabolic dysfunction.
Read the detailed description
We hypothesize that there are changes in circulating A-FABP level which can be mitigated by effective treatment of OSA.
The aim is to investigate the effect of CPAP treatment of OSA on circulating A-FABP, and other metabolic biomarkers and cardiovascular parameters
- Being tested
- continuous positive airway pressure
- Keywords
- obstructive sleep apnea, metabolic dysfunction, metabolic syndrome, adipocyte fatty acid binding protein
- Medical subject headings
- Sleep Apnea, Obstructive, Insulin Resistance, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure | Active comparator | using continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks) Receives: Device: continuous positive airway pressure |
| control | No intervention | observation for the study period (4 weeks, no CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adipocyte fatty acid binding protein
blood assay
Measured: changes over 4 weeks of CPAP treatment
Secondary outcomes (6)
Insulin and glucose
blood assay
Measured: changes over 4 weeks of CPAP treatment
Lipids and lipoprotein
blood assay
Measured: changes over 4 weeks of CPAP treatment
blood Markers of oxidative stress and fat metabolism
Measured: changes over 4 weeks of CPAP treatment
blood inflammatory markers
Measured: changes over 4 weeks of CPAP treatment
blood pressure
Measured: changes over 4 weeks of CPAP treatment
Epworth sleepiness scale
by sleep questionnaire
Measured: changes over 4 weeks of CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJun 2008
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Mary SM Ip, MD, Principal investigator, The University of Hong Kong, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173432
- Sponsor's protocol ID
- UW07-178
- Other IDs
- HKCTR-770
- Status last verified
- Apr 2019
- First submitted
- 29 Jul 2010
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu A, Wang Y, Xu JY, Stejskal D, Tam S, Zhang J, Wat NM, Wong WK, Lam KS. Adipocyte fatty acid-binding protein is a plasma biomarker closely associated with obesity and metabolic syndrome. Clin Chem. 2006 Mar;52(3):405-13. doi: 10.1373/clinchem.2005.062463. Epub 2006 Jan 19.
PubMed 16423904Stejskal D, Karpisek M. Adipocyte fatty acid binding protein in a Caucasian population: a new marker of metabolic syndrome? Eur J Clin Invest. 2006 Sep;36(9):621-5. doi: 10.1111/j.1365-2362.2006.01696.x.
PubMed 16919044Lam DC, Xu A, Lam KS, Lam B, Lam JC, Lui MM, Ip MS. Serum adipocyte-fatty acid binding protein level is elevated in severe OSA and correlates with insulin resistance. Eur Respir J. 2009 Feb;33(2):346-51. doi: 10.1183/09031936.50075408.
PubMed 19181913Lui MMS, Mak JCW, Chong PWC, Lam DCL, Ip MSM. Circulating adipocyte fatty acid-binding protein is reduced by continuous positive airway pressure treatment for obstructive sleep apnea-a randomized controlled study. Sleep Breath. 2020 Sep;24(3):817-824. doi: 10.1007/s11325-019-01893-5. Epub 2019 Aug 1.
PubMed 31372823
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Effect of Continuous Positive Airway Pressure on Adipocyte Fatty Acid Binding Protein and Other Metabolic Markers in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01173432
- Acronym / sponsor ID
- UW07-178
- Keywords
- obstructive sleep apnea, metabolic dysfunction, metabolic syndrome, adipocyte fatty acid binding protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Aug 2010 (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.
Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose metabolism have been described, and it is suggested to play an important role in the pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our group has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is present in the blood stream .The levels of A-FABP correlated with various metabolic variates in the metabolic syndrome. Furthermore, we have obtained novel data in men with a range of sleep disordered breathing showed that the duration of oxygen desaturation correlated with circulating levels of A-FABP, independent of age and waist/body mass index. The current proposal aims to pursue this finding and further explore the role of A-FABP in the association of OSA and metabolic dysfunction.
Detailed description
We hypothesize that there are changes in circulating A-FABP level which can be mitigated by effective treatment of OSA.
The aim is to investigate the effect of CPAP treatment of OSA on circulating A-FABP, and other metabolic biomarkers and cardiovascular parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure | Active comparator | Device: continuous positive airway pressureusing continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks) |
| control | No intervention | –observation for the study period (4 weeks, no CPAP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects between 18 - 65 years old
- Able to understand and give informed written consent
Key exclusion criteria (5 listed)
- BMI > 35 kg/m2, and features of obesity hypoventilation syndrome
- known diabetes mellitus or hyperlipidemia on treatment
- known cardiovascular disease except hypertension stable on treatment
- unstable medical illness
- need for starting treatment for OSA or other medical conditions immediately
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 |
|---|---|---|
| continuous positive airway pressurean device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway | Device | continuous positive airway pressure |
Primary outcome
adipocyte fatty acid binding protein
Time frame: changes over 4 weeks of CPAP treatment
blood assay
6 secondary outcomes
Insulin and glucose
Time frame: changes over 4 weeks of CPAP treatment
Lipids and lipoprotein
Time frame: changes over 4 weeks of CPAP treatment
blood Markers of oxidative stress and fat metabolism
Time frame: changes over 4 weeks of CPAP treatment
blood inflammatory markers
Time frame: changes over 4 weeks of CPAP treatment
blood pressure
Time frame: changes over 4 weeks of CPAP treatment
Epworth sleepiness scale
Time frame: changes over 4 weeks of CPAP treatment
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 17 Apr 2019.
- Background: PubMed 16423904Xu A, Wang Y, Xu JY, Stejskal D, Tam S, Zhang J, Wat NM, Wong WK, Lam KS. Adipocyte fatty acid-binding protein is a plasma biomarker closely associated with obesity and metabolic syndrome. Clin Chem. 2006 Mar;52(3):405-13. doi: 10.1373/clinchem.2005.062463. Epub 2006 Jan 19.
- Background: PubMed 16919044Stejskal D, Karpisek M. Adipocyte fatty acid binding protein in a Caucasian population: a new marker of metabolic syndrome? Eur J Clin Invest. 2006 Sep;36(9):621-5. doi: 10.1111/j.1365-2362.2006.01696.x.
- Background: PubMed 19181913Lam DC, Xu A, Lam KS, Lam B, Lam JC, Lui MM, Ip MS. Serum adipocyte-fatty acid binding protein level is elevated in severe OSA and correlates with insulin resistance. Eur Respir J. 2009 Feb;33(2):346-51. doi: 10.1183/09031936.50075408.
- Derived from this study: PubMed 31372823Lui MMS, Mak JCW, Chong PWC, Lam DCL, Ip MSM. Circulating adipocyte fatty acid-binding protein is reduced by continuous positive airway pressure treatment for obstructive sleep apnea-a randomized controlled study. Sleep Breath. 2020 Sep;24(3):817-824. doi: 10.1007/s11325-019-01893-5. Epub 2019 Aug 1.
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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.
Mary SM Ip, MD principal investigator
The University of Hong Kong, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure in people with Obstructive Sleep Apnea and Insulin Resistance, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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 17 Apr 2019. 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 Hong Kong. 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?
adipocyte fatty acid binding protein (time frame: changes over 4 weeks of CPAP treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01173432, which also lists 4 linked publications.
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 17 Apr 2019.