Treatment of Insomnia and Glucose Metabolism

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Plamen Penev, University of Chicago
ClinicalTrials.gov Identifier:
NCT00724282
First received: July 25, 2008
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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 Intervention
Sleep
Insomnia
Insulin Resistance
Drug: Eszopiclone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • plasma glucose level at the 120-minute time point of a 75g oral glucose tolerance test [ Time Frame: at the end of each treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • first phase insulin secretion in response to intravenous glucose [ Time Frame: at the end of each treatment ] [ Designated as safety issue: No ]
  • index of insulin sensitivity [ Time Frame: at the end of each treatment ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eszopiclone Drug: Eszopiclone
Eszopiclone 3 mg by mouth daily at bedtime for 7 days
Other Name: Lunesta
Placebo Comparator: Placebo Drug: Placebo
Placebo by mouth daily at bedtime for 7 days

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.

  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Both
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
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: NCT00724282

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

No publications provided

Responsible Party: Plamen Penev, Assistant Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00724282     History of Changes
Other Study ID Numbers: 15632, ESRC-124
Study First Received: July 25, 2008
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014