Impact of Exenatide on Sleep in Type 2 Diabetes

The University of Chicago

Status: Completed

Conditions: Sleep Disordered Breathing; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Exenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT01136798

09-291-B

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Usual T2 DM med regimen

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Usual T2 DM med regimen plus Exenatide

Experimental group

Description:

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.

Treatment:

Drug: Exenatide