Impact of Exenatide on Sleep in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01136798
First received: April 13, 2010
Last updated: September 4, 2013
Last verified: December 2012
  Purpose

The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.


Condition Intervention
Type 2 Diabetes
Sleep Disordered Breathing
Drug: Exenatide
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • minutes of non-REM slow wave sleep [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • total amount of slow wave activity during sleep derived from laboratory polysomnogram [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: June 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Usual Type 2 DM medication regimen
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Drug: Placebo
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
Experimental: Usual Type 2 DM medication treatment plus Exenatide
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Drug: Exenatide
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Exclusion Criteria:

  • Patients with unstable cardiac, neurological or psychiatric disease
  • Women who are pregnant or report trying to get pregnant will be excluded.
  • Patients treated for obstructive sleep apnea (OSA) will be excluded.
  • Patients with established OSA will be included only if they have declined treatment of OSA.
  • Patients with morbid obesity (BMI ≥ 40 gk/m2)
  • Patients on insulin
  • Patients already taking an incretin-based drug will not be included
  • Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
  • Patients taking an insulin secretagogue will be excluded.
  • Patients with Hemoglobin A1c values greater than or equal to 10 will be 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: NCT01136798

Contacts
Contact: Guglielmo Beccuti, MD 773 834-5845
Contact: Carol Touma, MD

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Eve Van Cauter, PhD    773-702-0169    evcauter@medicine.bsd.uchicago.edu   
Principal Investigator: Eve Van Cauter, PhD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Guglielmo Beccuti, MD    773-834-5845      
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01136798     History of Changes
Other Study ID Numbers: 09-291-B
Study First Received: April 13, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
slow wave sleep
effect of exenatide therapy on sleep in patients with type 2 diabetes

Additional relevant MeSH terms:
Respiratory Aspiration
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 19, 2014