Back to resultsEffect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Active
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Continuous positive airway pressure treatment
Liraglutide and CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Liraglutide, Continuous positive airway pressure, Insulin resistance, Vascular inflammation
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed moderate-severe OSA (by standard PSG)
- Body mass index between 30 - 40
- Age 18 - 60 years
- Able to provide written, informed consent
Exclusion Criteria:
- 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
- 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
Sites / Locations
- St Vincent's University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Continuous positive airway pressure (CPAP)
Liraglutide-based weight loss regimen
Combination CPAP/Liraglutide
Arm Description
Standard CPAP Therapy
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
Combination of both interventions
Outcomes
Primary Outcome Measures
Insulin resistance
Improvement in insulin resistance defined by HOMA-IR
Secondary Outcome Measures
Weight
Change in body mass index
Glucose tolerance
Change in glucose tolerance measured by oral glucose tolerance test
OSA Severity
Change in apnea/hypopnea index as per polysomnography
Blood pressure
Change in 24-hour blood pressure
Endothelial function
Change in microvascular endothelial function measured by EndoPat
Coronary artery calcification
Change in coronary artery calcification score determined by Coronary artery CT
Vascular inflammation
Change in vascular inflammation determined via FDG-PET scan
Full Information
NCT ID
NCT04186494
First Posted
December 2, 2019
Last Updated
January 28, 2022
Sponsor
St Vincent's University Hospital, Ireland
Collaborators
University College Dublin, Health Research Board, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT04186494
Brief Title
Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's University Hospital, Ireland
Collaborators
University College Dublin, Health Research Board, Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 in non-diabetic patients with moderate to severe obstructive sleep apnea
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Liraglutide, Continuous positive airway pressure, Insulin resistance, Vascular inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous positive airway pressure (CPAP)
Arm Type
Active Comparator
Arm Description
Standard CPAP Therapy
Arm Title
Liraglutide-based weight loss regimen
Arm Type
Experimental
Arm Description
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
Arm Title
Combination CPAP/Liraglutide
Arm Type
Experimental
Arm Description
Combination of both interventions
Intervention Type
Drug
Intervention Name(s)
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Intervention Description
GLP-1 analogue treatment in combination with advice on diet and physical exercise
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure treatment
Intervention Description
Gold standard treatment for obstructive sleep apnea
Intervention Type
Combination Product
Intervention Name(s)
Liraglutide and CPAP
Intervention Description
Combination of both treatments
Primary Outcome Measure Information:
Title
Insulin resistance
Description
Improvement in insulin resistance defined by HOMA-IR
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight
Description
Change in body mass index
Time Frame
6 months
Title
Glucose tolerance
Description
Change in glucose tolerance measured by oral glucose tolerance test
Time Frame
6 months
Title
OSA Severity
Description
Change in apnea/hypopnea index as per polysomnography
Time Frame
6 months
Title
Blood pressure
Description
Change in 24-hour blood pressure
Time Frame
6 months
Title
Endothelial function
Description
Change in microvascular endothelial function measured by EndoPat
Time Frame
6 months
Title
Coronary artery calcification
Description
Change in coronary artery calcification score determined by Coronary artery CT
Time Frame
6 months
Title
Vascular inflammation
Description
Change in vascular inflammation determined via FDG-PET scan
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed moderate-severe OSA (by standard PSG)
Body mass index between 30 - 40
Age 18 - 60 years
Able to provide written, informed consent
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silke Ryan, PhD, MD
Organizational Affiliation
St Vincent's University Hospital, University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's University Hospital
City
Dublin
State/Province
Dublin 4
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
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