Impact of Exenatide on Sleep in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136798
• Other study ID #: 09-291-B
• Status: Completed
• Phase: N/A
• Start date: June 1, 2010
• Est. completion date: September 1, 2016

Study information

• Verified date: August 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sleep Disordered Breathing
• Type 2 Diabetes

Intervention

Drug:
• Exenatide
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
• Placebo
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-REM Slow Wave Sleep	Total minutes of non-REM sleep was measured	baseline and after 6 weeks of treatment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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