Status:
COMPLETED
A Pilot Study of the Effects on Sleep Disordered Breathing (SDB) When Using the Drug Liraglutide for 4 Weeks
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Sleep Apnea
Sleep Disordered Breathing
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 liragluti...
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, Lira...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01832532
Start Date
April 1 2013
End Date
December 1 2015
Last Update
October 20 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229