Sleep Effectiveness and Insulin and Glucose Homeostasis
The purpose of this study is to examine the influence of sleep effectiveness on glucose and insulin metabolism in health and disease (prediabetes and type two diabetes).
We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal blood glucose and insulin measurements, and assess the impact of pharmacologic enhancement [using eszopiclon (Lunesta), a medication that promotes stable sleep)] on glucose and insulin homeostasis.
We hypothesize that 1: Effective sleep is associated with enhanced insulin sensitivity, relative to ineffective sleep states, and 2: Enhancing sleep effectiveness using eszopiclone (Lunesta) improves 24-hour glucose metabolism in prediabetics and diabetics compared to baseline.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sleep Effectiveness and Insulin and Glucose Homeostasis|
- change in continuous glucose profile [ Time Frame: comparing 72 hours of baseline and after 1 week of eszopiclone ] [ Designated as safety issue: No ]
- change in Sleep effectiveness biomarkers [ Time Frame: nightly comparing baseline with post-7 nights of eszopiclone ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
We will evaluate the impact of pharmacologic enhancement of effective sleep with nightly eszopiclone (taken before bedtime for 1 week, home environment) on glycemic profiles (continuous glucose monitoring, 72 hrs) in prediabetics and diabetics compared to pretreatment baseline. The dose of eszopiclone will be the lowest tolerated dose (1-3 mg) via dose escalation and side effect profile assessment.
Eszopiclone at a dose of 1-3 mg (lowest tolerated dose, as determined using a dose escalation schedule and side effect profile)will be taken 30 minutes before bedtime for one week.
Other Name: Lunesta
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887691
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Melanie Pogach, MD||Beth Israel Deaconess Medical Center|