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Impact of Exenatide on Sleep Duration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416649
Recruitment Status : Unknown
Verified September 2016 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : August 15, 2011
Last Update Posted : September 5, 2016
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: Exenatide

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes
Study Start Date : February 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Sleep duration and sleep efficiency [ Time Frame: at the end of 3 months of treatment with the medication ]
    Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416649

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Contact: Annette Miller, MSN 773-834-8871

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United States, Illinois
The University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Annette Miller, MSN    773-834-8871   
Principal Investigator: Silvana Pannain, MD         
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Silvana Pannain, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT01416649    
Other Study ID Numbers: 10-051-A
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists