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Completed

NCT Number: NCT04186494

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

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

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's University Hospital

Dublin, Dublin 4, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

continuous positive airway pressure treatment

Device

Gold standard treatment for obstructive sleep apnea

Liraglutide and CPAP

Combination Product

Combination of both treatments

Primary outcomes

  1. Insulin resistance

    Time frame: 6 months

    Improvement in insulin resistance defined by HOMA-IR

Secondary outcomes

  1. Weight

    Time frame: 6 months

    Change in body mass index

  2. Glucose tolerance

    Time frame: 6 months

    Change in glucose tolerance measured by oral glucose tolerance test

  3. OSA Severity

    Time frame: 6 months

    Change in apnea/hypopnea index as per polysomnography

  4. Blood pressure

    Time frame: 6 months

    Change in 24-hour blood pressure

  5. Endothelial function

    Time frame: 6 months

    Change in microvascular endothelial function measured by EndoPat

  6. Coronary artery calcification

    Time frame: 6 months

    Change in coronary artery calcification score determined by Coronary artery CT

  7. Vascular inflammation

    Time frame: 6 months

    Change in vascular inflammation determined via FDG-PET scan

Sponsors and collaborators

Lead sponsor

St Vincent's University Hospital, Ireland

Other

Collaborators

  • Health Research Board, Ireland
  • University College Dublin

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 4, 2019
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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