Treatment of Insomnia and Glucose Metabolism
Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
October 16, 2015
CompletedOctober 16, 2015
October 1, 2015
3.9 years
July 25, 2008
September 10, 2015
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
at the end of each treatment
Study Arms (1)
Eszopiclone or Placebo
OTHERSubjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Interventions
Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Eligibility Criteria
You may qualify if:
- age between 35 and 64
- must have long-standing trouble falling or staying asleep
- BMI between 22 and 34 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea Eiring
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Plamen D Penev, MD, PhD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
April 1, 2008
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 16, 2015
Results First Posted
October 16, 2015
Record last verified: 2015-10