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Impact of Exenatide on Sleep Duration

Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01416649
Enrollment
8
Registered
2011-08-15
Start date
2011-02-01
Completion date
2021-04-21
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide. Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.

Interventions

DRUGExenatide

Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible

Exclusion criteria

Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions. Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.

Design outcomes

Primary

MeasureTime frameDescription
Sleep duration and sleep efficiencyat the end of 3 months of treatment with the medicationSleep duration and efficiency will be measured using an activity monitor worn on the wrist.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026