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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT01832532
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
Sep 2020
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • No Intervention: Control group
    Control group

Primary Outcome Measure

Change in Apnea Hypopnea Index (AHI) From Baseline [ Time Frame: Baseline and 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

Find similar trials in Cincinnati, OH

By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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