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Impact of Exenatide on Sleep in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01136798
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

April 13, 2010
June 3, 2010
February 16, 2018
June 1, 2010
September 1, 2016   (Final data collection date for primary outcome measure)
  • minutes of non-REM slow wave sleep [ Time Frame: baseline and after 6 weeks of treatment ]
    Total minutes of non-REM sleep will be measured
  • total amount of slow wave activity during sleep derived from laboratory polysomnogram [ Time Frame: baseline and after 6 weeks of treatment ]
    Total amount of slow wave activity will be measured
  • difference in minutes of non-REM slow wave sleep [ Time Frame: 6 weeks ]
  • chang in total amount of slow wave activity during sleep derived from laboratory polysomnogram [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT01136798 on ClinicalTrials.gov Archive Site
  • sleep efficiency during polysomnographic recording [ Time Frame: baseline and after 6 weeks of treatment ]
    Sleep efficiency will be calculated as the percentage of sleep recording time spent in stages N1, N3, slow-wave sleep and REM sleep
  • minutes of Wake after Sleep Onset during sleep recording [ Time Frame: baseline and after 6 weeks of treatment ]
    total amount of time spent awake after sleep onset and before morning awakening will be calculated
  • Severity of obstructive sleep apnea [ Time Frame: baseline and after 6 weeks of treatment ]
    the apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings
  • mean 24-h blood glucose levels [ Time Frame: baseline and after 6 weeks of treatment ]
    Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle
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Impact of Exenatide on Sleep in Type 2 Diabetes
Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Sleep Disordered Breathing
  • Drug: Exenatide
    Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
  • Drug: Placebo
    Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
  • Placebo Comparator: Usual T2 DM med regimen
    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.
    Intervention: Drug: Placebo
  • Experimental: Usual T2 DM med regimen plus Exenatide
    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: Drug: Exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
56
September 1, 2016
September 1, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01136798
09-291-B
Not Provided
Not Provided
Plan to Share IPD: No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Eve Van Cauter, PhD University of Chicago
University of Chicago
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP