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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT04186494 (opens ClinicalTrials.gov in a new tab)Other idRS19-023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
30 participants (actual)
Sponsor
St Vincent's University Hospital, Ireland · Other
Design
Randomized · Single masking
Countries
1 country

Ireland

Start
2 Dec 2019
Primary completion
31 Dec 2021
Completion
31 Jul 2022
First posted
4 Dec 2019
Last update posted
18 Dec 2023
Conditions
Sleep Apnea, Obstructive

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. N/A

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

    NCT04186494

    2 Dec 2019 to 31 Jul 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlDrug
  • Continuous positive airway pressure treatmentDevice
  • Liraglutide and CPAPCombination product

Arms3

  • Active comparator

    Continuous positive airway pressure (CPAP)

    Standard CPAP Therapy

  • 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

  • Experimental

    Combination CPAP/Liraglutide

    Combination of both interventions

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Insulin resistance

    Time frame · 6 months

    Registry description

    Improvement in insulin resistance defined by HOMA-IR

Secondary outcomes(7)

  1. Weight

    Time frame · 6 months

    Registry description

    Change in body mass index

  2. Glucose tolerance

    Time frame · 6 months

    Registry description

    Change in glucose tolerance measured by oral glucose tolerance test

  3. OSA Severity

    Time frame · 6 months

    Registry description

    Change in apnea/hypopnea index as per polysomnography

  4. Blood pressure

    Time frame · 6 months

    Registry description

    Change in 24-hour blood pressure

  5. Endothelial function

    Time frame · 6 months

    Registry description

    Change in microvascular endothelial function measured by EndoPat

  6. Coronary artery calcification

    Time frame · 6 months

    Registry description

    Change in coronary artery calcification score determined by Coronary artery CT

  7. Vascular inflammation

    Time frame · 6 months

    Registry description

    Change in vascular inflammation determined via FDG-PET scan

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

8 results

Continuous Positive Airway Pressure but Not GLP1-mediated Weight Loss Improves Early Cardiovascular Disease in Obstructive Sleep Apnea: A Randomized Proof-of-Concept Study.

O'Donnell et al. 2024Annals of the American Thoracic Societycited by 53

PMID 38096106DOI 10.1513/annalsats.202309-821ocPUB-38096106

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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