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Tissue-specific Effects of Insufficient Sleep

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ClinicalTrials.gov Identifier: NCT03437681
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE February 12, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
Change in insulin sensitivity [ Time Frame: One week ]
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Changes in macrovascular function [ Time Frame: One week ]
    Macrovascular function will be assessed with flow-mediated dilation
  • Changes in microvascular function [ Time Frame: One week ]
    Macrovascular function will be assessed with EndoPAT
  • Changes in cognitive abilities [ Time Frame: One week ]
    Cognitive computer tests performed during study
  • Changes in circadian rhythms [ Time Frame: One week ]
    Salivary dim-light melatonin offset will be assessed
  • Changes in metabolic tissue function [ Time Frame: One week ]
    Tissue biopsies will be performed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tissue-specific Effects of Insufficient Sleep
Official Title  ICMJE Tissue-specific Effects of Insufficient Sleep
Brief Summary This study plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.
Detailed Description Participants will stay in the hospital for 6 days and will not be able to leave. Sleep habits will be measured for 7 days before the study. A research diet that is designed to maintain weight will be provided for 3 days before the study and during the study. Multiple tests will be performed, including metabolic testing and muscle and fat biopsies, both when participants first arrive and have had normal sleep and again after 4 nights of only 5 hours time in bed. The visit takes place at the Clinical Translational Research Center (CTRC) at the University of Colorado Denver, Anschutz Medical campus. It will take approximately 2 weeks to complete this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
The project is a within-subject consecutive design examining 18 healthy individuals after baseline and after 4 nights of insufficient sleep.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: Insufficient sleep
Four days of insufficient sleep
Study Arms  ICMJE Experimental: Insufficient sleep
Each participant will receive 4 nights of insufficient sleep.
Intervention: Behavioral: Insufficient sleep
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2018)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Healthy, lean participants.
  2. No regular physical activity (<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
  3. Habitual sleep duration between 7-9.25h. Subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission.
  4. Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.

Exclusion Criteria:

  1. Current or history of any clinically significant medical, psychiatric, or sleep disorder.
  2. Use or history of any drugs, medications, supplements, caffeine, and alcohol.
  3. Current or history of shiftwork in six months prior to laboratory study.
  4. Travel more than one time zone in three weeks prior to laboratory study.
  5. Blood donation in the 30 days prior to inpatient study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Josiane L. Broussard, PhD 303-735-1923 josiane.broussard@colorado.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03437681
Other Study ID Numbers  ICMJE 17-0533
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josiane L. Broussard, PhD University of Colorado, Boulder
PRS Account University of Colorado, Denver
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP