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

NCT01832532 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-10-20

Study results available
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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.

Conditions

Interventions

DRUG

liraglutide

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

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Raouf Amin, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832532 on ClinicalTrials.gov