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Impact of Exenatide on Sleep Duration

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01416649
First received: August 11, 2011
Last updated: September 4, 2013
Last verified: June 2013
  Purpose

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 ] [ Designated as safety issue: No ]
    Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.


Estimated Enrollment: 12
Study Start Date: February 2011
Estimated Primary Completion Date: December 2013 (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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Convenience Sample

Criteria

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 ClinicalTrials.gov identifier: NCT01416649

Contacts
Contact: Annette Miller, MSN 773-834-8871 amiller@medicine.bsd.uchicago.edu

Locations
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    amiller@medicine.bsd.uchicago.edu   
Principal Investigator: Silvana Pannain, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Silvana Pannain, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01416649     History of Changes
Other Study ID Numbers: 10-051-A
Study First Received: August 11, 2011
Last Updated: September 4, 2013
Health Authority: United Sates: The University of Chicago Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014