Impact of Exenatide on Sleep in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study

Conditions
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Type 2 Diabetes, Sleep Disordered Breathing

Intervention / Treatment
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* Drug: Exenatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual T2 DM med regimen<br>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<br>* Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks<br>|
| Experimental: Usual T2 DM med regimen plus Exenatide<br>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<br>* Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-REM Slow Wave Sleep | Total minutes of non-REM sleep was measured | baseline and after 6 weeks of treatment | 
| Total Amount of Slow Wave Activity | Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured | baseline and after 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency During Polysomnographic Recording | Sleep efficiency will be calculated as total sleep time over total recording time. | baseline and after 6 weeks of treatment | 
| Minutes of Wake After Sleep Onset During Sleep Recording | total amount of time spent awake after sleep onset and before morning awakening will be calculated | baseline and after 6 weeks of treatment | 
| Severity of Obstructive Sleep Apnea | The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea. | baseline and after 6 weeks of treatment | 
| Mean 24-h Blood Glucose Levels | Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle. | baseline and after 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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slow wave sleep, exenatide and sleep