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Impact of Exenatide on Sleep Duration
This study is currently recruiting participants.
Verified August 2011 by University of Chicago
Study NCT01416649   Information provided by University of Chicago

First Received on August 11, 2011.   No Changes Posted

August 11, 2011
August 11, 2011
February 2011
December 2011   (final data collection date for primary outcome measure)
Sleep duration and sleep efficiency [ Time Frame: at the end of 3 months of treatment with the medication ] [ Designated as safety issue: No ]
Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.
Same as current
No Changes Posted
 
 
 
 
 
Impact of Exenatide on Sleep Duration
Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes

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.

 
Interventional
 
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Type 2 Diabetes
Drug: Exenatide
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.
Other Name: The brand name of exenatide is Byetta.
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
 
December 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact: Annette Miller, MSN 773-834-8871 amiller@medicine.bsd.uchicago.edu
United States
 
NCT01416649
10-051-A
No
Silvana Pannain, MD, Assistant Professor, The University of Chicagp
University of Chicago
 
Principal Investigator: Silvana Pannain, MD University of Chicago
University of Chicago
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP