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Treatment of Insomnia and Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00724282
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Sleep Insomnia Insulin Resistance Drug: Eszopiclone Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Eszopiclone or Placebo
Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Drug: Eszopiclone
Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Other Name: Lunesta
Drug: Placebo
Placebo by mouth daily at bedtime for 9 days


Outcome Measures

Primary Outcome Measures :
  1. Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test [ Time Frame: at the end of each treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724282


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Plamen D Penev, MD, PhD University of Chicago
More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724282     History of Changes
Other Study ID Numbers: 15632
ESRC-124
First Posted: July 29, 2008    Key Record Dates
Results First Posted: October 16, 2015
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by University of Chicago:
sleep
eszopiclone
insulin secretion
insulin action
glucose tolerance

Additional relevant MeSH terms:
Insulin Resistance
Sleep Initiation and Maintenance Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Insulin, Globin Zinc
Insulin
Eszopiclone
Hypoglycemic Agents
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants