Phase 4
N=20
Treatment of Insomnia and Glucose Metabolism
Sleep · Insomnia · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT00724282 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eszopiclone (Drug); Placebo (Drug)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00724282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.