Back to resultsImpact of Exenatide on Sleep in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Sleep Disordered Breathing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring slow wave sleep, exenatide and sleep
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.
Exclusion Criteria:
- Patients with unstable cardiac, neurological or psychiatric disease
- Women who are pregnant or report trying to get pregnant will be excluded.
- Patients treated for obstructive sleep apnea (OSA) will be excluded.
- Patients with established OSA will be included only if they have declined treatment of OSA.
- Patients with morbid obesity (BMI ≥ 40 gk/m2)
- Patients on insulin
- Patients already taking an incretin-based drug will not be included
- Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
- Patients taking an insulin secretagogue will be excluded.
- Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.
Sites / Locations
- The University of Chicago
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Usual T2 DM med regimen
Usual T2 DM med regimen plus Exenatide
Arm Description
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Outcomes
Primary Outcome Measures
Non-REM Slow Wave Sleep
Total minutes of non-REM sleep was measured
Total Amount of Slow Wave Activity
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
Secondary Outcome Measures
Sleep Efficiency During Polysomnographic Recording
Sleep efficiency will be calculated as total sleep time over total recording time.
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
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.
Mean 24-h Blood Glucose Levels
Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01136798
Brief Title
Impact of Exenatide on Sleep in Type 2 Diabetes
Official Title
Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2010 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
5. Study Description
Brief Summary
The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Sleep Disordered Breathing
Keywords
slow wave sleep, exenatide and sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual T2 DM med regimen
Arm Type
Placebo Comparator
Arm Description
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Arm Title
Usual T2 DM med regimen plus Exenatide
Arm Type
Experimental
Arm Description
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Non-REM Slow Wave Sleep
Description
Total minutes of non-REM sleep was measured
Time Frame
baseline and after 6 weeks of treatment
Title
Total Amount of Slow Wave Activity
Description
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
Time Frame
baseline and after 6 weeks of treatment
Secondary Outcome Measure Information:
Title
Sleep Efficiency During Polysomnographic Recording
Description
Sleep efficiency will be calculated as total sleep time over total recording time.
Time Frame
baseline and after 6 weeks of treatment
Title
Minutes of Wake After Sleep Onset During Sleep Recording
Description
total amount of time spent awake after sleep onset and before morning awakening will be calculated
Time Frame
baseline and after 6 weeks of treatment
Title
Severity of Obstructive Sleep Apnea
Description
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.
Time Frame
baseline and after 6 weeks of treatment
Title
Mean 24-h Blood Glucose Levels
Description
Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.
Time Frame
baseline and after 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.
Exclusion Criteria:
Patients with unstable cardiac, neurological or psychiatric disease
Women who are pregnant or report trying to get pregnant will be excluded.
Patients treated for obstructive sleep apnea (OSA) will be excluded.
Patients with established OSA will be included only if they have declined treatment of OSA.
Patients with morbid obesity (BMI ≥ 40 gk/m2)
Patients on insulin
Patients already taking an incretin-based drug will not be included
Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
Patients taking an insulin secretagogue will be excluded.
Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eve Van Cauter, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Exenatide on Sleep in Type 2 Diabetes
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