N/A
N=20
Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00555750 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test — .33; -0.10 %/min, slope of natural log glucose
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- eszopiclone (Drug); placebo (Drug)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test |
.33; -0.10 | — |
| SECONDARY Acute Insulin Response to Glucose (AIRg) |
94.0; 25.1 | — |
| SECONDARY Change in Insulin Sensitivity (SI) |
-1.19; 0.05 | — |
| SECONDARY Change in Glucose Effectiveness (SG) |
0.001; 0.001 | — |
| SECONDARY Change in HbA1c Levels |
.03; -.09 | — |
| SECONDARY Pre-Treatment Leptin Levels |
4.99; 16.53 | — |
| SECONDARY Post-treatment Leptin Levels |
5.49; 15.28 | — |
| SECONDARY Pre-treatment Ghrelin Levels |
573.14; 648.41 | — |
| SECONDARY Post-treatment Ghrelin Levels |
544.95; 670.94 | — |
| SECONDARY Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS) |
0.53; 0.38 | — |
| SECONDARY Change in Mean Lapses of Attention |
-0.04; 0.07 | — |
| SECONDARY Change in Total Sleep Time as Reported in Sleep Diaries |
.58; .09 | — |
| SECONDARY Change in Total Sleep Time Measured by PSG |
2.9; -6.4 | — |
Summary
The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA.
Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia
Eligibility Criteria
Inclusion Criteria
- Age 25-55
- Complaint of insomnia of at least 6 months duration
- DSM-IV diagnosis of Primary Insomnia
- Sleep diary: mean Total Sleep Time 32 or 2 caffeinated beverages per day (including coffee, tea and/or other caffeine-containing beverages or food) during 3 weeks prior to the start of the study
Data sourced from ClinicalTrials.gov (NCT00555750). 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.