Impact of Exenatide on Sleep in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Sleep Disordered Breathing
• Interventions: Drug: Placebo; Drug: Exenatide

• Registration Number: NCT01136798
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-13
• Study Start: 2010-06-01
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-01
• Results First Submitted: 2018-02-23
• Results First Submitted QC: 2018-07-05
• Results First Posted: 2018-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual T2 DM med regimen	Placebo	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.
Usual T2 DM med regimen plus Exenatide	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Minutes of Wake After Sleep Onset During Sleep Recording	baseline and after 6 weeks of treatment	total amount of time spent awake after sleep onset and before morning awakening will be calculated
Severity of Obstructive Sleep Apnea	baseline and after 6 weeks of treatment	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.
Sleep Efficiency During Polysomnographic Recording	baseline and after 6 weeks of treatment	Sleep efficiency will be calculated as total sleep time over total recording time.
Mean 24-h Blood Glucose Levels	baseline and after 6 weeks of treatment	Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.

Trial Locations

Locations (2)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States