Treatment of Insomnia and Glucose Metabolism

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724282
• Other study ID #: 15632
• Secondary ID: ESRC-124
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2008
• Last updated: October 15, 2015
• Start date: April 2008
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Insulin Resistance
• Sleep

Intervention

Drug:
• Eszopiclone
Eszopiclone 3 mg by mouth daily at bedtime for 9 days
• Placebo
Placebo by mouth daily at bedtime for 9 days

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test		at the end of each treatment	No