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Sleep Loss and Mechanisms of Impaired Glucose Metabolism

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Insomnia

Intervention: eszopiclone (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
John W Winkelman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Summary

The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U. S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA. Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia

Clinical Details

Official title: The Effects of Eszopiclone Treatment (3mg for Two Months) to Counteract the Adverse Metabolic Consequences of Primary Insomnia

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test

Secondary outcome:

Acute Insulin Response to Glucose (AIRg)

Change in Insulin Sensitivity (SI)

Change in Glucose Effectiveness (SG)

Change in HbA1c Levels

Pre-Treatment Leptin Levels

Post-treatment Leptin Levels

Pre-treatment Ghrelin Levels

Post-treatment Ghrelin Levels

Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)

Change in Mean Lapses of Attention

Change in Total Sleep Time as Reported in Sleep Diaries

Change in Total Sleep Time Measured by PSG

Detailed description: Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any given year, and chronically affecting 10-15% of the adult population. Reduced sleep time, independent of insomnia, has been associated with a variety of deleterious long term effects, including an increased risk of incident myocardial infarction and symptomatic diabetes. Chronic partial sleep loss or insomnia may impair glucose metabolism in the short term and are associated with the development of diabetes in the long term. Although the extent of sleep loss is more acute in the laboratory-based 'sleep debt' studies of healthy volunteers, chronic primary insomnia patients exhibit 'hyperarousal' (hypercortisolemia in the afternoon and evening, accelerated metabolism) similar to that seen with acute sleep deprivation. In addition, degradations of sleep quantity and quality in primary insomnia have been attributed to cognitive and somatic hyperarousal in the sleep setting. study examines and quantifies in adult men and women the link between primary insomnia and impaired glucose tolerance. This study examines the extent which adequate treatment of primary insomnia reverses impairments of glucose metabolism. If abnormalities of glucose metabolism are reversible, this study will demonstrate the importance of treatment of chronic primary insomnia.

Eligibility

Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 25-55

- Complaint of insomnia of at least 6 months duration

- DSM-IV diagnosis of Primary Insomnia

- Sleep diary: mean Total Sleep Time < 6 hours and a mean total wake time (sleep

latency + wake after sleep onset) of greater than 60 minutes (in previous 14 days as recorded on sleep diary)

- A willingness to comply with study procedures

- If of child-bearing potential, using a medically-accepted method of birth control,

including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, and intrauterine device [IUD]) Exclusion Criteria:

- Current diagnosis of DSM-IV Axis I disorder other than Primary Insomnia

- Regular treatment (more than 1 time/week) with CNS active medication within 1 month

of fist inpatient visit

- Treatment with medications that interfere with glucose metabolism including

anti-diabetic medications or steroidal contraceptives

- Uncontrolled medical illness that would interfere with participation in the study

- Body Mass Index >32 or <19. 8

- Current symptoms or diagnosis of any moderate to severe sleep disorder other than

insomnia

- No menopausal or peri-menopausal symptoms that disrupt sleep

- Pregnant, lactating or planning to become pregnant

- Consumption of > 2 caffeinated beverages per day (including coffee, tea and/or other

caffeine-containing beverages or food) during 3 weeks prior to the start of the study

Locations and Contacts

Brigham and Women's Hospital, Division of Sleep Medicine, Boston, Massachusetts 02115, United States
Additional Information

Related publications:

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Starting date: March 2006
Last updated: November 15, 2013

Page last updated: August 23, 2015

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