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A Pilot Study of the Effects on Sleep Disordered Breathing (SDB) When Using the Drug Liraglutide for 4 Weeks

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ClinicalTrials.gov Identifier: NCT01832532
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:

This is an open label, controlled study.

The investigators are studying if the FDA approved diabetes medicine liraglutide (Victoza®) can improve sleep apnea in adults. This study is testing liraglutide in 20 adults without diabetes that are diagnosed with sleep apnea.The treatment group will be compared to a control group of 10 adults without diabetes who have sleep apnea but will not use liraglutide. Both groups will continue receiving standard of care for their sleep apnea as prescribed by their managing sleep physician throughout their study participation.

Everyone in the study will have two study visits and one overnight sleep study for research. Subjects who have not had a recent sleep study but otherwise qualify for the study, will have an additional research sleep study to determine the baseline severity of their sleep apnea. The study visits include fasting blood samples and breathing tests (pulmonary function test and hypercapnic challenge). There will be weekly phone visits that include a questionnaire on sleepiness. The group that takes liraglutide will check their blood sugar two times a day while on the medicine.


Condition or disease Intervention/treatment Phase
Sleep Apnea Sleep Disordered Breathing Drug: liraglutide Phase 1 Phase 2

Detailed Description:

This is a pilot study aimed at measuring the change in obstructive apnea/hypopnea index in non-diabetic patients being treated for the first time with the glucagon-like peptide-1 (GLP-1) agonist, Liraglutide. Sleep disordered breathing (SDB) consists of nocturnal alveolar hypoventilation and / or obstructive sleep apnea which result from abnormalities in upper airway tone and ventilation during sleep. The development of a new pharmacological treatment for sleep disordered breathing (SDB) could bring a breakthrough discovery that will impact a rapidly growing population of children and adults with this disorder. The investigators hypothesize that GLP-1 plays a central role in the improvement of SDB and that the administration of GLP-1 receptor agonist to patients with OSA will correct or improve SDB.

  • Hypothesis 1: Administration of Liraglutide to patients with severe OSA defined as apnea hypopnea index ≥ 8 /hr. will result in a mean reduction in the index by a minimum of 50% after 4 weeks.
  • Hypothesis 2: Administration of Liraglutide will result in significant increase in Orexin level, decrease in leptin, decrease in Epworth Sleepiness Scale (ESS) score and increase in carbon dioxide (CO2) chemosensitivity.

This is an open label, non-randomized, controlled pilot study. Subjects are heavy to obese non-diabetic adults that are diagnosed with sleep apnea. 20 subjects will be treated with liraglutide for 4 weeks and compared to 10 untreated controls.

Study time points are baseline and 4 weeks post treatment. Study procedures include pre and post treatment: fasting blood for glucose, hemoglobin A1C (HbA1C), Orexin and leptin; ESS questionnaire; pulmonary function test and hypercapnic challenge. The procedures also include a post treatment overnight research sleep study to measure change in apnea index from diagnostic sleep study done previous to study enrollment or if needed, the baseline research sleep study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot 2: Glucagon-like Peptide-1 in Sleep Disordered Breathing
Study Start Date : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Treatment group- liraglutide
Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.
Drug: liraglutide
daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
Other Name: Other name- Victoza

No Intervention: Control group
Control group



Primary Outcome Measures :
  1. Change in apnea hypopnea index (AHI) from baseline [ Time Frame: At 4 week endpoint ]
    Decrease of AHI at end of study in treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-60 years
  • Diagnosis of severe obstructive sleep apnea (OSA) AHI ≥ 8 /hour of sleep
  • Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule
  • BMI of ≥ 27
  • For Cohort 1: If female of childbearing capacity, willing to use acceptable birth control during use of study drug

Exclusion Criteria:

  • A major medical condition such as renal or hepatic failure
  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
  • Diagnosis of type 1 or type 2 diabetes per judgment of the investigator
  • BMI < 27
  • History of glycosylated hemoglobin (HbA1c) equal to or above 6.5%
  • Significant craniofacial abnormalities that may cause OSA
  • Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
  • Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone or drugs in the incretin family within the previous 3 months prior to screening
  • Previous surgical treatment for obesity
  • Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
  • Personal or immediate family history of thyroid cancer
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • History of Major Depressive Disorder or suicide attempts
  • Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
  • History of alcoholism
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832532


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Raouf Amin, MD Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01832532     History of Changes
Other Study ID Numbers: CIN001Pilot 2GLP
UL1RR026314 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Manuscript is in progress.
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Sleep Apnea
Sleep Disordered Breathing
liraglutide
glucagon-like peptide-1 agonist
Orexin
leptin,
Additional relevant MeSH terms:
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Liraglutide
Sleep Apnea Syndromes
Respiratory Aspiration
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents