N/A
N=18
Impact of Exenatide on Sleep in Type 2 Diabetes
Type 2 Diabetes · Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT01136798 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Non-REM Slow Wave Sleep — 47.3; 34.3; 57.3; 41.4 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exenatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-REM Slow Wave Sleep |
47.3; 34.3; 57.3; 41.4 | — |
| PRIMARY Total Amount of Slow Wave Activity |
— | — |
| SECONDARY Sleep Efficiency During Polysomnographic Recording |
84.3; 85.3; 83.8; 89.4 | — |
| SECONDARY Minutes of Wake After Sleep Onset During Sleep Recording |
70.4; 56.6; 52.3; 36.6 | — |
| SECONDARY Severity of Obstructive Sleep Apnea |
15.9; 16.4; 16.5; 10.9 | — |
| SECONDARY Mean 24-h Blood Glucose Levels |
134.4; 142.2; 141.3; 136.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01136798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.