NCT04186494

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

December 2, 2019

Last Update Submit

December 15, 2023

Conditions

Sleep Apnea, Obstructive

Keywords

LiraglutideContinuous positive airway pressureInsulin resistanceVascular inflammation

Outcome Measures

Primary Outcomes (1)

  • Insulin resistance

    Improvement in insulin resistance defined by HOMA-IR

    6 months

Secondary Outcomes (7)

  • Weight

    6 months

  • Glucose tolerance

    6 months

  • OSA Severity

    6 months

  • Blood pressure

    6 months

  • Endothelial function

    6 months

  • +2 more secondary outcomes

Study Arms (3)

Continuous positive airway pressure (CPAP)

ACTIVE COMPARATOR

Standard CPAP Therapy

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

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

Combination CPAP/Liraglutide

EXPERIMENTAL

Combination of both interventions

Combination Product: Liraglutide and CPAP

Interventions

Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlDRUG

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

Liraglutide-based weight loss regimen
Continuous positive airway pressure treatmentDEVICE

Gold standard treatment for obstructive sleep apnea

Continuous positive airway pressure (CPAP)
Liraglutide and CPAPCOMBINATION_PRODUCT

Combination of both treatments

Combination CPAP/Liraglutide

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Newly diagnosed moderate-severe OSA (by standard PSG)
  • Body mass index between 30 - 40
  • Age 18 - 60 years
  • Able to provide written, informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's University Hospital

Dublin, Dublin 4, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 38096106DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveInsulin Resistance

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Silke Ryan, PhD, MD

    St Vincent's University Hospital, University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Consultant in Respiratory and Sleep Medicine

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 4, 2019

Study Start

December 2, 2019

Primary Completion

December 31, 2021

Study Completion

July 31, 2022

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)