Sleep Effectiveness and Insulin and Glucose Homeostasis
|ClinicalTrials.gov Identifier: NCT01887691|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : April 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Prediabetic Prediabetes Glucose Intolerance||Drug: eszopiclone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Effectiveness and Insulin and Glucose Homeostasis|
|Study Start Date :||October 2012|
|Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2018|
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 ]
- change in Sleep effectiveness biomarkers [ Time Frame: nightly comparing baseline with post-7 nights of eszopiclone ]
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|