Impact of Exenatide on Sleep in Type 2 Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes, Sleep Disordered Breathing

In brief

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.

Key facts

Study ID

NCT01136798

Run by

University of Chicago

People needed

18

Starts

2010-06-01

Expected to finish

2016-09-01

Last updated by the study team

2018-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

You may not qualify if…

• 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.

Where it is running

• The University of Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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