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Treatment of Insomnia and Glucose Metabolism

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep; Insomnia; Insulin Resistance

Intervention: Eszopiclone (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Plamen D Penev, MD, PhD, Principal Investigator, Affiliation: University of Chicago

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: plasma glucose level at the 120-minute time point of a 75g oral glucose tolerance test

Secondary outcome:

first phase insulin secretion in response to intravenous glucose

index of insulin sensitivity

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.

Eligibility

Minimum age: 35 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States
Additional Information

Starting date: April 2008
Last updated: March 28, 2012

Page last updated: August 23, 2015

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