Treatment of Insomnia and Glucose Metabolism

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00724282
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 47
• Patients Per Site Per Month: 0.4

Study Details

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
• 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: Apr 1, 2008
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: 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 [at the end of each treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00724282
• Other Study ID Numbers: 15632; ESRC-124
• First Posted: Jul 29, 2008
• Last Update Posted: Oct 16, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by University of Chicago: sleep; eszopiclone; insulin secretion; insulin action; glucose tolerance
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Insulin Resistance; Eszopiclone

Study Results

Participant Flow

Pre-assignment Detail	Investigator left academia and is unavailable; participation in cross-over sequences was not unblinded, therefore participants are presented in one Arm throughout Results.

Arm/Group Title	Eszopiclone or Placebo
Arm/Group Description	Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Period Title: Overall Study
STARTED	20
COMPLETED	16
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Eszopiclone or Placebo
Arm/Group Description	Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	14 70%
Male	6 30%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 55%
White	8 40%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Investigator left university without analyzing data and no information is available on unblinding.

Arm/Group Title	Eszopiclone or Placebo
Arm/Group Description	Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Measure Participants	0

Adverse Events

Arm/Group Title	Eszopiclone or Placebo
Arm/Group Description	Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
All Cause Mortality
	Eszopiclone or Placebo
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Eszopiclone or Placebo
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Eszopiclone or Placebo
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Skin and subcutaneous tissue disorders
Furuncle	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.