Impact of Exenatide on Sleep in Type 2 Diabetes
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Sleep Disordered Breathing
Intervention: Exenatide (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Eve Van Cauter, PhD, Principal Investigator, Affiliation: University of Chicago
Overall contact: Guglielmo Beccuti, MD, Phone: 773 834-5845
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.
Clinical Details
Official title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: minutes of non-REM slow wave sleeptotal amount of slow wave activity during sleep derived from laboratory polysomnogram
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Guglielmo Beccuti, MD, Phone: 773 834-5845
The University of Chicago, Chicago, Illinois 60637, United States; Recruiting Eve Van Cauter, PhD, Phone: 773-702-0169, Email: evcauter@medicine.bsd.uchicago.edu Eve Van Cauter, PhD, Principal Investigator
University of Chicago, Chicago, Illinois 60637, United States; Recruiting Guglielmo Beccuti, MD, Phone: 773-834-5845
Additional Information
Starting date: June 2010
Last updated: December 5, 2014
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