Treatment of Insomnia and Glucose Metabolism

Phase 4

Completed

• Conditions: Sleep; Insomnia; Insulin Resistance
• Interventions: Drug: Eszopiclone; Drug: Placebo

• Registration Number: NCT00724282
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2015-09-10
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-15
• Last Update Submitted: 2015-10-15
• Results First Posted: 2015-10-16
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eszopiclone or Placebo	Placebo	Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Eszopiclone or Placebo	Eszopiclone	Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.

Primary Outcome Measures

Name	Time	Method
Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test	at the end of each treatment

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States