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Impact of Exenatide on Sleep

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01136798
First received: April 13, 2010
Last updated: December 9, 2010
Last verified: December 2010
History of Changes
  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
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

Drug Information available for: Exenatide
U.S. FDA Resources

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: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Exenatide
    Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 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
  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)
  • Patiets 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
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: Eve Van Cauter, PhD, Professor, The 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: December 9, 2010
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
Signs and Symptoms, Respiratory
Signs and Symptoms
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

ClinicalTrials.gov processed this record on May 21, 2013