Back to resultsTreatment of Insomnia and Glucose Metabolism
Primary Purpose
Sleep, Insomnia, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep focused on measuring sleep, eszopiclone, insulin secretion, insulin action, glucose tolerance
Eligibility Criteria
Inclusion Criteria:
- age between 35 and 64
- must have long-standing trouble falling or staying asleep
- BMI between 22 and 34 kg/m2
Exclusion Criteria:
- sleep apnea or other sleep disorder other than insomnia
- diagnosis of diabetes requiring treatment with pills or insulin
- smoking
- night or shift work
- presence of a medical condition that can disrupt sleep
- women only: irregular menstrual periods or pregnancy
- use of medications/compounds that can disrupt sleep
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Eszopiclone or Placebo
Arm Description
Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Outcomes
Primary Outcome Measures
Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724282
Brief Title
Treatment of Insomnia and Glucose Metabolism
Official Title
Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.
Detailed Description
Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Insomnia, Insulin Resistance
Keywords
sleep, eszopiclone, insulin secretion, insulin action, glucose tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eszopiclone or Placebo
Arm Type
Other
Arm Description
Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo by mouth daily at bedtime for 9 days
Primary Outcome Measure Information:
Title
Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
Time Frame
at the end of each treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age between 35 and 64
must have long-standing trouble falling or staying asleep
BMI between 22 and 34 kg/m2
Exclusion Criteria:
sleep apnea or other sleep disorder other than insomnia
diagnosis of diabetes requiring treatment with pills or insulin
smoking
night or shift work
presence of a medical condition that can disrupt sleep
women only: irregular menstrual periods or pregnancy
use of medications/compounds that can disrupt sleep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Plamen D Penev, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Insomnia and Glucose Metabolism
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