Sleep Apnea, ObstructiveNCT04186494
Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
A study testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml, Continuous positive airway pressure treatment and Liraglutide and CPAP in people with Sleep Apnea, Obstructive, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial summary
This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml, Continuous positive airway pressure treatment and Liraglutide and CPAP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 2 Dec 2019to 31 Jul 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed moderate-severe OSA (by standard PSG)
- Body mass index between 30 - 40
- Age 18 - 60 years
- Able to provide written, informed consent
Who cannot join
- Pregnancy
- Requirement for supplemental oxygen
- Previous diagnosis of OSA or previous CPAP treatment
- Diagnosis of Diabetes
- Previous treatment with GLP-1 analogue
- Previous surgical treatment for obesity
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- Active treatment for malignancy or severe psychiatric disorder
- Acute coronary syndrome or stroke within 3 months prior to study
- History of decompensated heart failure
- Professional drivers or drivers with a history of road-traffic accident due to sleepiness
- Severe excessive daytime sleepiness defined as Epworth sleepiness scale >15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study
This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml, Continuous positive airway pressure treatment, Liraglutide and CPAP
- Keywords
- Liraglutide, Continuous positive airway pressure, Insulin resistance, Vascular inflammation
- Medical subject headings
- Sleep Apnea, Obstructive, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlDrug
GLP-1 analogue treatment in combination with advice on diet and physical exercise
Continuous positive airway pressure treatmentDevice
Gold standard treatment for obstructive sleep apnea
Liraglutide and CPAPCombination product
Combination of both treatments
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure (CPAP) | Active comparator | Standard CPAP Therapy Receives: Device: Continuous positive airway pressure treatment |
| Liraglutide-based weight loss regimen | Experimental | Once daily s.c. injections of Liraglutide, starting at a dose of 0.6 mg with weekly 0.6 mg increments to 3.0 mg in adjunct to advice on a weight-reduction diet and physical exercise Receives: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml |
| Combination CPAP/Liraglutide | Experimental | Combination of both interventions Receives: Combination Product: Liraglutide and CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Improvement in insulin resistance defined by HOMA-IR
Measured: 6 months
Secondary outcomes (7)
Weight
Change in body mass index
Measured: 6 months
Glucose tolerance
Change in glucose tolerance measured by oral glucose tolerance test
Measured: 6 months
OSA Severity
Change in apnea/hypopnea index as per polysomnography
Measured: 6 months
Blood pressure
Change in 24-hour blood pressure
Measured: 6 months
Endothelial function
Change in microvascular endothelial function measured by EndoPat
Measured: 6 months
Coronary artery calcification
Change in coronary artery calcification score determined by Coronary artery CT
Measured: 6 months
Vascular inflammation
Change in vascular inflammation determined via FDG-PET scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start2 Dec 2019
- Primary completion31 Dec 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, Health Research Board, Ireland
- Responsible party
- Principal investigator, Dr Silke Ryan, St Vincent's University Hospital, Ireland
- Investigators
- Silke Ryan, PhD, MD, Principal investigator, St Vincent's University Hospital, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186494
- Sponsor's protocol ID
- RS19-023
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2019
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Donnell C, Crilly S, O'Mahony A, O'Riordan B, Traynor M, Gitau R, McDonald K, Ledwidge M, O'Shea D, Murphy DJ, Dodd JD, Ryan S. Continuous Positive Airway Pressure but Not GLP1-mediated Weight Loss Improves Early Cardiovascular Disease in Obstructive Sleep Apnea: A Randomized Proof-of-Concept Study. Ann Am Thorac Soc. 2024 Mar;21(3):464-473. doi: 10.1513/AnnalsATS.202309-821OC.
PubMed 38096106
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT04186494
- Acronym / sponsor ID
- RS19-023
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Liraglutide, Continuous positive airway pressure, Insulin resistance, Vascular inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Collaborators
- University College Dublin, Health Research Board, Ireland
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 4 Dec 2019 (actual)
- 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.
This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure (CPAP) | Active comparator | Device: Continuous positive airway pressure treatmentStandard CPAP Therapy |
| Liraglutide-based weight loss regimen | Experimental | Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlOnce daily s.c. injections of Liraglutide, starting at a dose of 0.6 mg with weekly 0.6 mg increments to 3.0 mg in adjunct to advice on a weight-reduction diet and physical exercise |
| Combination CPAP/Liraglutide | Experimental | Combination Product: Liraglutide and CPAPCombination of both interventions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Newly diagnosed moderate-severe OSA (by standard PSG)
- Body mass index between 30 - 40
- Age 18 - 60 years
- Able to provide written, informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Requirement for supplemental oxygen
- Previous diagnosis of OSA or previous CPAP treatment
- Diagnosis of Diabetes
- Previous treatment with GLP-1 analogue
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 |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlGLP-1 analogue treatment in combination with advice on diet and physical exercise | Drug | Liraglutide-based weight loss regimen |
| Continuous positive airway pressure treatmentGold standard treatment for obstructive sleep apnea | Device | Continuous positive airway pressure (CPAP) |
| Liraglutide and CPAPCombination of both treatments | Combination product | Combination CPAP/Liraglutide |
Primary outcome
Insulin resistance
Time frame: 6 months
Improvement in insulin resistance defined by HOMA-IR
7 secondary outcomes
Weight
Time frame: 6 months
Glucose tolerance
Time frame: 6 months
OSA Severity
Time frame: 6 months
Blood pressure
Time frame: 6 months
Endothelial function
Time frame: 6 months
Coronary artery calcification
Time frame: 6 months
Vascular inflammation
Time frame: 6 months
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 18 Dec 2023.
- Derived from this study: PubMed 38096106O'Donnell C, Crilly S, O'Mahony A, O'Riordan B, Traynor M, Gitau R, McDonald K, Ledwidge M, O'Shea D, Murphy DJ, Dodd JD, Ryan S. Continuous Positive Airway Pressure but Not GLP1-mediated Weight Loss Improves Early Cardiovascular Disease in Obstructive Sleep Apnea: A Randomized Proof-of-Concept Study. Ann Am Thorac Soc. 2024 Mar;21(3):464-473. doi: 10.1513/AnnalsATS.202309-821OC.
- Individual participant dataSharing planned: No
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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.
Silke Ryan, PhD, MD principal investigator
St Vincent's University Hospital, University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml, Continuous positive airway pressure treatment and Liraglutide and CPAP in people with Sleep Apnea, Obstructive, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
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 4 inclusion and 11 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 18 Dec 2023. 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 Ireland. 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?
Insulin resistance (time frame: 6 months). 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 NCT04186494, which also lists 1 linked publication.
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 18 Dec 2023.