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Completed

NCT Number: NCT00724282

Treatment of Insomnia and Glucose Metabolism

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.

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Key information

Conditions

Sleep Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Insomnia Insulin Resistance Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eszopiclone

Drug

Eszopiclone 3 mg by mouth daily at bedtime for 9 days

Other names: Lunesta

Placebo

Drug

Placebo by mouth daily at bedtime for 9 days

Primary outcomes

  1. Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test

    Time frame: at the end of each treatment

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2008
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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