Sleep Loss and Mechanisms of Impaired Glucose Metabolism

NCT00555750 | Completed Results

• 3 other identifiers: BWH-HRC-2005-P-001997ESRC0004M01RR002635
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Primary Insomnia

Keywords

sleep; metabolism; insulin; glucose; actigraphy; diary; volumetry; GABA

Outcome Measures

Primary Outcomes (1)

• Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test

  Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.

  baseline and 2 months post-treatment

Secondary Outcomes (12)

• Acute Insulin Response to Glucose (AIRg)

  baseline and 2 months post-treatment

• Change in Insulin Sensitivity (SI)

  baseline and 2 months post-treatment

• Change in Glucose Effectiveness (SG)

  baseline and 2 months post-treatment

• Change in HbA1c Levels

  baseline and 2 months post-treatment

• Pre-Treatment Leptin Levels

  baseline

Study Arms (2)

eszopiclone (3mg)

EXPERIMENTAL

active medication (eszopiclone 3mg tablet) by mouth nightly 30 min before bed

Drug: eszopiclone

placebo

PLACEBO COMPARATOR

identical placebo tablet by mouth nightly 30 min before bed

Drug: placebo

Interventions

eszopiclone DRUG

3mg tablet, by mouth nightly 30 min before bed, for two months

Also known as: Lunesta

eszopiclone (3mg)

placebo DRUG

inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months

placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[IUD\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Sumitomo Pharma America, Inc.: collaborator
• Mclean Hospital: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Brigham and Women's Hospital, Division of Sleep Medicine

Boston, Massachusetts, 02115, United States

Location

Related Publications (22)

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  BACKGROUND

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  PMID: 10607036 BACKGROUND

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  BACKGROUND

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  PMID: 7939123 BACKGROUND

• Gottlieb DJ, Punjabi NM, Newman AB, Resnick HE, Redline S, Baldwin CM, Nieto FJ. Association of sleep time with diabetes mellitus and impaired glucose tolerance. Arch Intern Med. 2005 Apr 25;165(8):863-7. doi: 10.1001/archinte.165.8.863.

  PMID: 15851636 BACKGROUND

• Hoddes E, Dement WC and Zarcone V. The development and use of the Stanford Sleepiness Scale (SSS). Psychophysiol 9: 150, 1971.

  BACKGROUND

• King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.

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• Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, Salonen JT. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA. 2002 Dec 4;288(21):2709-16. doi: 10.1001/jama.288.21.2709.

  PMID: 12460094 BACKGROUND

• Nilsson PM, Roost M, Engstrom G, Hedblad B, Berglund G. Incidence of diabetes in middle-aged men is related to sleep disturbances. Diabetes Care. 2004 Oct;27(10):2464-9. doi: 10.2337/diacare.27.10.2464.

  PMID: 15451917 BACKGROUND

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• Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8.

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• Spiegel K, Tasali E, Penev P, Van Cauter E. Brief communication: Sleep curtailment in healthy young men is associated with decreased leptin levels, elevated ghrelin levels, and increased hunger and appetite. Ann Intern Med. 2004 Dec 7;141(11):846-50. doi: 10.7326/0003-4819-141-11-200412070-00008.

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  PMID: 12683469 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Insulin Resistance

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. John Winkelman, MD, PhD
• Organization: Brigham and Women's Hospital

jwwinkelman@partners.org

617-278-0061

Study Officials

• John W Winkelman, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: March 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 10, 2013
• Results First Posted: September 25, 2013

Record last verified: 2013-11

Locations

US (1)