Insomnia, Insulin Resistance, Sleep
Conditions
Keywords
sleep, eszopiclone, insulin secretion, insulin action, glucose tolerance
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.
Interventions
DRUGEszopiclone
Eszopiclone 3 mg by mouth daily at bedtime for 9 days
DRUGPlacebo
Placebo by mouth daily at bedtime for 9 days
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test | at the end of each treatment |
Countries
United States
Participant flow
Pre-assignment details
Investigator left academia and is unavailable; participation in cross-over sequences was not unblinded, therefore participants are presented in one Arm throughout Results.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Placebo: Placebo by mouth daily at bedtime for 9 days | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Eszopiclone or Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
Time frame: at the end of each treatment
Population: Investigator left university without analyzing data and no information is available on unblinding.