Tissue-specific Effects of Insufficient Sleep

Healthy Clinical Trial

Official title:

Tissue-specific Effects of Insufficient Sleep

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03437681
• Other study ID #: 17-0533
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Sleep Deprivation

Intervention

Behavioral:
• Insufficient sleep
Four days of insufficient sleep

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity	Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.	One week
Secondary	Changes in macrovascular function	Macrovascular function will be assessed with flow-mediated dilation	One week
Secondary	Changes in microvascular function	Macrovascular function will be assessed with EndoPAT	One week
Secondary	Changes in cognitive abilities	Cognitive computer tests performed during study	One week
Secondary	Changes in circadian rhythms	Salivary dim-light melatonin offset will be assessed	One week
Secondary	Changes in metabolic tissue function	Tissue biopsies will be performed	One week

External Links

•   Full list of publications