Sleep Loss and Mechanisms of Impaired Glucose Metabolism

This study has been completed.

Sponsor:

Collaborators:

Sunovion

Mclean Hospital

National Center for Research Resources (NCRR)

Information provided by (Responsible Party):

John W. Winkelman, MD, PhD, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00555750

First received: November 7, 2007

Last updated: November 15, 2013

Last verified: November 2013

History of Changes

Results First Received: May 21, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
Condition:	Primary Insomnia
Interventions:	Drug: eszopiclone Drug: placebo

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Eszopiclone	nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
Placebo	nightly placebo (identical tablet to active medication) oral administration ~30 min before bed

Participant Flow: Overall Study

	Eszopiclone	Placebo
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Active	active medication administration nightly before bed
Placebo	nightly administration of placebo before bed
Total	Total of all reporting groups

Baseline Measures

	Active	Placebo	Total
Overall Participants Analyzed [Units: Participants]	10	10	20

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	10	10	20
>=65 years	0	0	0

Gender [Units: Participants]
Female	2	7	9
Male	8	3	11

Region of Enrollment [Units: Participants]
United States	10	10	20

Outcome Measures

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1. Primary:

Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test [ Time Frame: baseline and 2 months post-treatment ]

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2. Secondary:

Acute Insulin Response to Glucose (AIRg) [ Time Frame: baseline and 2 months post-treatment ]

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3. Secondary:

Change in Insulin Sensitivity (SI) [ Time Frame: baseline and 2 months post-treatment ]

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4. Secondary:

Change in Glucose Effectiveness (SG) [ Time Frame: baseline and 2 months post-treatment ]

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5. Secondary:

Change in HbA1c Levels [ Time Frame: baseline and 2 months post-treatment ]

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6. Secondary:

Pre-Treatment Leptin Levels [ Time Frame: baseline ]

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7. Secondary:

Post-treatment Leptin Levels [ Time Frame: two months post-treatment ]

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8. Secondary:

Pre-treatment Ghrelin Levels [ Time Frame: baseline ]

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9. Secondary:

Post-treatment Ghrelin Levels [ Time Frame: 2 months post-treatment ]

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10. Secondary:

Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS) [ Time Frame: baseline and 2 months post-treatment ]

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11. Secondary:

Change in Mean Lapses of Attention [ Time Frame: baseline and 2 months post-treatment ]

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12. Secondary:

Change in Total Sleep Time as Reported in Sleep Diaries [ Time Frame: baseline and 2 months post-treatment ]

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13. Secondary:

Change in Total Sleep Time Measured by PSG [ Time Frame: baseline and 2 months post-treatment ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. John Winkelman, MD, PhD
Organization: Brigham and Women's Hospital
phone: 617-278-0061
e-mail: jwwinkelman@partners.org

Publications:

Ayas NT, White DP, Al-Delaimy WK, Manson JE, Stampfer MJ, Speizer FE, Patel S, Hu FB. A prospective study of self-reported sleep duration and incident diabetes in women. Diabetes Care. 2003 Feb;26(2):380-4.

Ayas NT, White DP, Manson JE, Stampfer MJ, Speizer FE, Malhotra A, Hu FB. A prospective study of sleep duration and coronary heart disease in women. Arch Intern Med. 2003 Jan 27;163(2):205-9.

Beck-Nielsen H, Henriksen JE, Alford F, Hother-Nielson O. In vivo glucose metabolism, insulin secretion and, insulin action in Europids with non-insulin-dependent diabetes mellitus (NIDDM) and their first-degree relatives. Diabet Med. 1996 Sep;13(9 Suppl 6):S78-84. Review.

Belenky G, Wesensten NJ, Thorne DR, Thomas ML, Sing HC, Redmond DP, Russo MB, Balkin TJ. Patterns of performance degradation and restoration during sleep restriction and subsequent recovery: a sleep dose-response study. J Sleep Res. 2003 Mar;12(1):1-12.

Boyne MS, Saudek CD. Effect of insulin therapy on macrovascular risk factors in type 2 diabetes. Diabetes Care. 1999 Apr;22 Suppl 3:C45-53. Review.

Buxton OM, Spiegel K and Van Cauter E. Modulation of endocrine function and metabolism by sleep and sleep loss. In: Sleep Medicine, edited by Lee-Chiong M, Carskadon M and Sateia M. Philadelphia: Hanley & Belfus, Inc., 2002, p. 59-69.

Buysse DJ, Jarrett DB, Miewald JM, Kupfer DJ, Greenhouse JB. Minute-by-minute analysis of REM sleep timing in major depression. Biol Psychiatry. 1990 Nov 15;28(10):911-25.

Czeisler CA, Winkelman JW and Richardson GS. Disorders of sleep and circadian rhythms. In: Harrison's Principles of Internal Medicine, edited by Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL and Jameson JL. New York: McGraw-Hill,Inc., 2000, p. 1-78.

Dijk DJ, Duffy JF, Czeisler CA. Circadian and sleep/wake dependent aspects of subjective alertness and cognitive performance. J Sleep Res. 1992 Jun;1(2):112-7.

Dinges DF, Kribbs NB, Bates BL and Carlin MM. A very brief probed-recall memory task: Sensitivity to sleep loss. Sleep Res 22: 330, 1993.

Dinges DF and Powell JW. Microcomputer analyses of performance on a portable, simple visual RT task during sustained operations. Behavior Research Methods, Instruments & Computers 17: 652-655, 1985.

Gillberg M, Kecklund G, Akerstedt T. Relations between performance and subjective ratings of sleepiness during a night awake. Sleep. 1994 Apr;17(3):236-41.

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.

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

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.

King H, Zimmet P. Trends in the prevalence and incidence of diabetes: non-insulin-dependent diabetes mellitus. World Health Stat Q. 1988;41(3-4):190-6.

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.

Nilsson PM, Rööst M, Engström 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.

Simon GE, VonKorff M. Prevalence, burden, and treatment of insomnia in primary care. Am J Psychiatry. 1997 Oct;154(10):1417-23.

Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9.

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.

Van Dongen HP, Maislin G, Mullington JM, Dinges DF. The cumulative cost of additional wakefulness: dose-response effects on neurobehavioral functions and sleep physiology from chronic sleep restriction and total sleep deprivation. Sleep. 2003 Mar 15;26(2):117-26. Erratum in: Sleep. 2004 Jun 15;27(4):600.

Responsible Party:	John W. Winkelman, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00555750 History of Changes
Other Study ID Numbers:	BWH-HRC-2005-P-001997 ESRC0004 ( Other Grant/Funding Number: Sunovion previously Sepracor Inc ) M01RR002635 ( U.S. NIH Grant/Contract )
Study First Received:	November 7, 2007
Results First Received:	May 21, 2013
Last Updated:	November 15, 2013

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