Treatment of Insomnia and Glucose Metabolism

NCT ID: NCT00724282

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-03-31

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.

Conditions

Sleep; Insomnia; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: OTHER

Eszopiclone

Intervention Type: DRUG

Eszopiclone 3 mg by mouth daily at bedtime for 9 days

Placebo

Intervention Type: DRUG

Placebo by mouth daily at bedtime for 9 days

Interventions

Eszopiclone

Eszopiclone 3 mg by mouth daily at bedtime for 9 days

Intervention Type: DRUG

Placebo

Placebo by mouth daily at bedtime for 9 days

Intervention Type: DRUG

Other Intervention Names

Lunesta

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Plamen D Penev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

ESRC-124

Identifier Type: -

Identifier Source: secondary_id

15632

Identifier Type: -

Identifier Source: org_study_id