Treatment of Insomnia and Glucose Metabolism - Full Text View

Sponsor:	University of Chicago
Collaborator:	Sepracor, Inc.
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00724282

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:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
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:

Drug Information available for: Insulin Dextrose Eszopiclone

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Eszopiclone: Active Comparator	Drug: Eszopiclone Eszopiclone 3 mg by mouth daily at bedtime for 7 days
Placebo: Placebo Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724282

Contacts

Contact: Plamen D Penev, MD, PhD	(773) 702-5125	ppenev@medicine.bsd.uchicago.edu
Contact: Kaveeta Vasisht, MD	(773) 834-5905	kvasisht@medicine.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Plamen D Penev, MD, PhD

Sponsors and Collaborators

University of Chicago

Sepracor, Inc.

Investigators

Principal Investigator:

Plamen D Penev, MD, PhD

University of Chicago

More Information

No publications provided

Responsible Party:	University of Chicago ( Plamen D. Penev, MD, PhD )
Study ID Numbers:	15632, ESRC-124
Study First Received:	July 25, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00724282 History of Changes
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:

Sleep Initiation and Maintenance Disorders
Hyperinsulinism
Metabolic Diseases
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Insulin Resistance
Glucose Metabolism Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 08, 2010