Sleep Effectiveness and Insulin and Glucose Homeostasis

NCT01887691 | Terminated Phase 1

• 1 other identifier: 2012P000187
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 \[using eszopiclone (Lunesta), a medication that promotes stable sleep)\] 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.

Conditions

Diabetes; Prediabetic; Prediabetes; Glucose Intolerance

Keywords

Diabetes; Prediabetic; Prediabetes; Glucose intolerance; Sleep quality; Continuous glucose monitoring; Diabetes risk; eszopiclone

Outcome Measures

Primary Outcomes (1)

• change in continuous glucose profile

  continuous glucose monitoring (CGM) results - mean daytime, post prandial and nocturnal glucose between baseline and after 1 week of eszopiclone

  comparing 72 hours of baseline and after 1 week of eszopiclone

Secondary Outcomes (1)

• change in Sleep effectiveness biomarkers

  nightly comparing baseline with post-7 nights of eszopiclone

Study Arms (1)

eszopiclone

EXPERIMENTAL

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.

Drug: eszopiclone

Interventions

eszopiclone DRUG

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.

Also known as: Lunesta

eszopiclone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 22215928 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Officials

• Melanie Pogach, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 27, 2013
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2019
• Last Updated: December 19, 2019

Record last verified: 2018-08

Locations

US (1)