| Trial ID: | L7091 |
| Source ID: | NCT01136798
|
| Associated Drug: |
Exenatide
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| Title: |
Impact of Exenatide on Sleep in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01136798/results
|
| Conditions: |
Type 2 Diabetes|Sleep Disordered Breathing
|
| Interventions: |
DRUG: Exenatide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Non-REM Slow Wave Sleep, Total minutes of non-REM sleep was measured, baseline and after 6 weeks of treatment|Total Amount of Slow Wave Activity, Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured, baseline and after 6 weeks of treatment | Secondary: Sleep Efficiency During Polysomnographic Recording, Sleep efficiency will be calculated as total sleep time over total recording time., baseline and after 6 weeks of treatment|Minutes of Wake After Sleep Onset During Sleep Recording, total amount of time spent awake after sleep onset and before morning awakening will be calculated, baseline and after 6 weeks of treatment|Severity of Obstructive Sleep Apnea, The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea., baseline and after 6 weeks of treatment|Mean 24-h Blood Glucose Levels, Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle., baseline and after 6 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: University of Chicago
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-06-01
|
| Completion Date: |
2016-09-01
|
| Results First Posted: |
2018-07-31
|
| Last Update Posted: |
2018-09-12
|
| Locations: |
The University of Chicago, Chicago, Illinois, 60637, United States|University of Chicago, Chicago, Illinois, 60637, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01136798
|
