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Impact of Exenatide on Sleep Duration

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by University of Chicago
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: August 11, 2011
Last updated: September 1, 2016
Last verified: September 2016

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 Intervention
Type 2 Diabetes Drug: Exenatide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 12
Study Start Date: February 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01416649

Contact: Annette Miller, MSN 773-834-8871

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
Principal Investigator: Silvana Pannain, MD University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT01416649     History of Changes
Other Study ID Numbers: 10-051-A
Study First Received: August 11, 2011
Last Updated: September 1, 2016

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on June 23, 2017