Impact of Exenatide on Sleep in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01136798
First received: April 13, 2010
Last updated: September 4, 2013
Last verified: December 2012

April 13, 2010
September 4, 2013
June 2010
December 2013   (final data collection date for primary outcome measure)
  • minutes of non-REM slow wave sleep [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • total amount of slow wave activity during sleep derived from laboratory polysomnogram [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • difference in minutes of non-REM slow wave sleep [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • chang in total amount of slow wave activity during sleep derived from laboratory polysomnogram [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01136798 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Type 2 DM medication 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 Type 2 DM medication treatment 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
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December 2013   (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.
Both
18 Years and older
No
Contact: Guglielmo Beccuti, MD 773 834-5845
Contact: Carol Touma, MD
United States
 
NCT01136798
09-291-B
Not Provided
University of Chicago
University of Chicago
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Principal Investigator: Eve Van Cauter, PhD University of Chicago
University of Chicago
December 2012

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