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CompletedNCT01416649Updated Apr 26, 2023

Impact of Exenatide on Sleep Duration

An observational study in Type 2 Diabetes, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by University of Chicago · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 8 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Convenience Sample

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

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.

    Also known as: The brand name of exenatide is Byetta.

06

What researchers measure

Primary outcomes

  1. Sleep duration and sleep efficiency

    Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.

    Time frame: at the end of 3 months of treatment with the medication

07

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01416649
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Aug 15, 2011
Start date
Feb 1, 2011
Primary completion
Apr 21, 2021
Completion
Apr 21, 2021
Last update
Apr 26, 2023

Study contacts

Silvana Pannain, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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