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Tracking Information | |||||
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First Received Date ICMJE | August 11, 2011 | ||||
Last Updated Date | August 11, 2011 | ||||
Start Date ICMJE | February 2011 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of Exenatide on Sleep Duration | ||||
Official Title ICMJE | Impact of Exenatide on Sleep Duration and Quality in 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
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Condition ICMJE | Type 2 Diabetes | ||||
Intervention ICMJE | 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. |
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Study Arms | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 12 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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. |
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01416649 | ||||
Other Study ID Numbers ICMJE | 10-051-A | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Silvana Pannain, MD, Assistant Professor, The University of Chicagp | ||||
Study Sponsor ICMJE | University of Chicago | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of Chicago | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |