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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Sleep Disordered Breathing Drug: Exenatide Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
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.
Drug: Placebo
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

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.
Drug: Exenatide
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136798


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01136798     History of Changes
Other Study ID Numbers: 09-291-B
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Chicago:
slow wave sleep
exenatide and sleep

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists