Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea

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

Sponsors

Lead Sponsor: St Vincent's University Hospital, Ireland

Collaborator: University College Dublin
Health Research Board, Ireland

Source St Vincent's University Hospital, Ireland
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

Overall Status Recruiting
Start Date December 2, 2019
Completion Date March 31, 2022
Primary Completion Date December 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Insulin resistance 6 months
Secondary Outcome
Measure Time Frame
Weight 6 months
Glucose tolerance 6 months
OSA Severity 6 months
Blood pressure 6 months
Endothelial function 6 months
Coronary artery calcification 6 months
Vascular inflammation 6 months
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Description: GLP-1 analogue treatment in combination with advice on diet and physical exercise

Arm Group Label: Liraglutide-based weight loss regimen

Intervention Type: Device

Intervention Name: Continuous positive airway pressure treatment

Description: Gold standard treatment for obstructive sleep apnea

Arm Group Label: Continuous positive airway pressure (CPAP)

Intervention Type: Combination Product

Intervention Name: Liraglutide and CPAP

Description: Combination of both treatments

Arm Group Label: Combination CPAP/Liraglutide

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Silke Ryan, PhD, MD Principal Investigator St Vincent's University Hospital, University College Dublin
Overall Contact

Last Name: Silke Ryan, PhD, MD

Phone: +35312213702

Email: [email protected]

Location
Facility: Status: Contact: St Vincent's University Hospital Silke Ryan +35312213702 [email protected]
Location Countries

Ireland

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: St Vincent's University Hospital, Ireland

Investigator Full Name: Dr Silke Ryan

Investigator Title: Associate Professor, Consultant in Respiratory and Sleep Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Continuous positive airway pressure (CPAP)

Type: Active Comparator

Description: Standard CPAP Therapy

Label: Liraglutide-based weight loss regimen

Type: Experimental

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

Label: Combination CPAP/Liraglutide

Type: Experimental

Description: Combination of both interventions

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov