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

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 Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Continuous positive airway pressure treatment; Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml; Combination product: Liraglutide and CPAP

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin 4
    • Dublin, Dublin 4, Ireland
      • St Vincent's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous positive airway pressure (CPAP); Standard CPAP Therapy	Device: Continuous positive airway pressure treatment; Gold standard treatment for obstructive sleep apnea
Experimental: Liraglutide-based weight loss regimen; 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	Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml; GLP-1 analogue treatment in combination with advice on diet and physical exercise
Experimental: Combination CPAP/Liraglutide; Combination of both interventions	Combination product: Liraglutide and CPAP; Combination of both treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance	Improvement in insulin resistance defined by HOMA-IR	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Change in body mass index	6 months
Glucose tolerance	Change in glucose tolerance measured by oral glucose tolerance test	6 months
OSA Severity	Change in apnea/hypopnea index as per polysomnography	6 months
Blood pressure	Change in 24-hour blood pressure	6 months
Endothelial function	Change in microvascular endothelial function measured by EndoPat	6 months
Coronary artery calcification	Change in coronary artery calcification score determined by Coronary artery CT	6 months
Vascular inflammation	Change in vascular inflammation determined via FDG-PET scan	6 months

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland
• Collaborators: University College Dublin; Health Research Board, Ireland
• Investigators: Principal Investigator: Silke Ryan, PhD, MD, St Vincent's University Hospital, University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Insulin resistance; Liraglutide; Continuous positive airway pressure; Vascular inflammation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: RS19-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No