Sleep Effectiveness and Insulin and Glucose Homeostasis
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|ClinicalTrials.gov Identifier: NCT01887691|
Recruitment Status : Terminated
First Posted : June 27, 2013
Last Update Posted : December 19, 2019
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 eszopiclone (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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Prediabetic Prediabetes Glucose Intolerance||Drug: eszopiclone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Effectiveness and Insulin and Glucose Homeostasis|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2019|
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
- change in continuous glucose profile [ Time Frame: comparing 72 hours of baseline and after 1 week of eszopiclone ]continuous glucose monitoring (CGM) results - mean daytime, post prandial and nocturnal glucose between baseline and after 1 week of eszopiclone
- change in Sleep effectiveness biomarkers [ Time Frame: nightly comparing baseline with post-7 nights of eszopiclone ]M1 results - percentage of high frequency coupling at baseline compared to after 7 nights eszopiclone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887691
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Melanie Pogach, MD||Beth Israel Deaconess Medical Center|