Sleep Effectiveness and Insulin and Glucose Homeostasis
Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Prediabetic; Prediabetes; Glucose Intolerance
Intervention: eszopiclone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Beth Israel Deaconess Medical Center Official(s) and/or principal investigator(s): Melanie Pogach, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center
Overall contact: Melanie Pogach, MD, Phone: 617-667-5864, Email: alee16@bidmc.harvard.edu
Summary
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.
Clinical Details
Official title: Sleep Effectiveness and Insulin and Glucose Homeostasis
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change in continuous glucose profile
Secondary outcome: change in Sleep effectiveness biomarkers
Detailed description:
Evidence from experimental studies supports the hypothesis that fragmented or insufficient
sleep contributes to impaired glucose and insulin homeostasis. The sleep spectrogram, an
EEG-independent measure of sleep effectiveness, maps coupled oscillations of heart rate
variability and ECG-derived respiration. In a sample of non-diabetic subjects with and
without sleep apnea, we previously explored the association between ECG-spectrogram derived
biomarkers and glucose metabolism and found that the marker of effective sleep, High
Frequency Coupling (HFC), is associated with reduced diabetes risk (increased Disposition
Index). HFC is also enhanced by sedative medications (unpublished data). In this study we
will 1.) explore the relationship between sleep effectiveness and insulin sensitivity across
the sleep period, by frequently sampling glucose and insulin during nocturnal
polysomnography in healthy and prediabetic subjects; and 2.) evaluate the impact of
pharmacologic enhancement of effective sleep with nightly eszopiclone (1 week, home
environment) on glycemic profiles (continuous glucose monitoring, 72 hrs) in prediabetics
and diabetics compared to pretreatment baseline. We expect that desirable glycemic profiles
will correlate with the spectrographic marker of effective sleep while undesirable glucose
profiles will correlate with the marker of ineffective sleep. Using pharmacologic
enhancement of effective sleep, we expect to demonstrate improvement in glycemic profiles in
prediabetic and diabetic subjects compared to pre-treatment baseline.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy volunteers, men and women 18-64 years of age.
- Fluent English speakers.
- Health status as per criteria listed for prediabetes and diabetes (based on 2003
American Diabetes Association criteria and 2009 International Expert Committee
Report: Prediabetics will have impaired glucose tolerance with fasting plasma glucose
(FPG) 100-125 mg/dL, Hemoglobin A1C 5. 7-6. 4%, or 2-hour plasma glucose (PG) 140-199
mg/dL after 75-g oral glucose tolerance test (OGTT). Diabetics will have FPG ≥ 126
mg/dL, Hemoglobin A1C ≥ 6. 5%, or 2-hour PG ≥ 200 mg/dL on OGTT.
Exclusion Criteria:
- Primary psychiatric disease or conditions which may independently contribute to sleep
fragmentation or may hinder the subject's ability to complete the proposed testing:
- Respiratory, liver, or clotting disorders
- History of sleep disordered breathing, Restless legs syndrome or Periodic limb
movement disorder or high clinical suspicion of sleep disordered breathing or other
sleep disorder (e. g., snoring, excessive daytime sleepiness, frequent napping,
excessive motor activity)
- Shift worker or circadian phase disorder
- Abnormal resting ECG, pacemaker, atrial fibrillation or other arrhythmia
- Seizure disorder
- History of depression, bipolar disorder, anxiety disorder, schizophrenia or use of
psychiatric medication
- Narcolepsy
- Tobacco or recreational drug use
- Pregnancy or lactation
- Regular use of stimulants or hypnotic medication
- Evidence of sleep apnea (Apnea-Hypopnea Index > 10 on screening sleep study)
Locations and Contacts
Melanie Pogach, MD, Phone: 617-667-5864, Email: alee16@bidmc.harvard.edu
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Additional Information
Related publications: Pogach MS, Punjabi NM, Thomas N, Thomas RJ. Electrocardiogram-based sleep spectrogram measures of sleep stability and glucose disposal in sleep disordered breathing. Sleep. 2012 Jan 1;35(1):139-48. doi: 10.5665/sleep.1604.
Starting date: October 2012
Last updated: June 25, 2013
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