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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

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Insufficient sleep Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
Official Title: Tissue-specific Effects of Insufficient Sleep
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Insufficient sleep
Each participant will receive 4 nights of insufficient sleep.
Behavioral: Insufficient sleep
Four days of insufficient sleep




Primary Outcome Measures :
  1. Change in insulin sensitivity [ Time Frame: One week ]
    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.


Secondary Outcome Measures :
  1. Changes in macrovascular function [ Time Frame: One week ]
    Macrovascular function will be assessed with flow-mediated dilation

  2. Changes in microvascular function [ Time Frame: One week ]
    Macrovascular function will be assessed with EndoPAT

  3. Changes in cognitive abilities [ Time Frame: One week ]
    Cognitive computer tests performed during study

  4. Changes in circadian rhythms [ Time Frame: One week ]
    Salivary dim-light melatonin offset will be assessed

  5. Changes in metabolic tissue function [ Time Frame: One week ]
    Tissue biopsies will be performed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437681


Contacts
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Contact: Josiane L. Broussard, PhD 303-735-1923 josiane.broussard@colorado.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Josiane Broussard       sleep.study@colorado.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Josiane L. Broussard, PhD University of Colorado, Boulder

Additional Information:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03437681     History of Changes
Other Study ID Numbers: 17-0533
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Sleep
Blood Sugar