- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437681
Tissue-specific Effects of Insufficient Sleep
November 28, 2023 updated by: University of Colorado, Denver
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- Healthy, lean participants.
- No regular physical activity (<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
- 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.
- Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.
Exclusion Criteria:
- Current or history of any clinically significant medical, psychiatric, or sleep disorder.
- Use or history of any drugs, medications, supplements, caffeine, and alcohol.
- Current or history of shiftwork in six months prior to laboratory study.
- Travel more than one time zone in three weeks prior to laboratory study.
- Blood donation in the 30 days prior to inpatient study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Insufficient sleep
Each participant will receive 4 nights of insufficient sleep.
|
Four days of insufficient sleep
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in insulin sensitivity
Time Frame: One week
|
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in macrovascular function
Time Frame: One week
|
Macrovascular function will be assessed with flow-mediated dilation
|
One week
|
|
Changes in microvascular function
Time Frame: One week
|
Macrovascular function will be assessed with EndoPAT
|
One week
|
|
Changes in cognitive abilities
Time Frame: One week
|
Cognitive computer tests performed during study
|
One week
|
|
Changes in circadian rhythms
Time Frame: One week
|
Salivary dim-light melatonin offset will be assessed
|
One week
|
|
Changes in metabolic tissue function
Time Frame: One week
|
Tissue biopsies will be performed
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Josiane L. Broussard, PhD, University of Colorado, Boulder
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2018
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
February 6, 2018
First Submitted That Met QC Criteria
February 12, 2018
First Posted (Actual)
February 19, 2018
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0533
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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