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Tissue-specific Effects of Insufficient Sleep

Primary Purpose

Healthy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Insufficient sleep

About this trial

This is an interventional basic science trial for Healthy focused on measuring Sleep, Blood Sugar

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insufficient sleep

Arm Description

Each participant will receive 4 nights of insufficient sleep.

Outcomes

Primary Outcome Measures

Change in insulin sensitivity

Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.

Secondary Outcome Measures

Changes in macrovascular function

Macrovascular function will be assessed with flow-mediated dilation

Changes in microvascular function

Macrovascular function will be assessed with EndoPAT

Changes in cognitive abilities

Cognitive computer tests performed during study

Changes in circadian rhythms

Salivary dim-light melatonin offset will be assessed

Changes in metabolic tissue function

Tissue biopsies will be performed

Full Information

NCT ID

NCT03437681

First Posted

February 6, 2018

Last Updated

August 12, 2022

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT03437681

Brief Title

Tissue-specific Effects of Insufficient Sleep

Official Title

Tissue-specific Effects of Insufficient Sleep

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 12, 2018 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Sleep, Blood Sugar

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Insufficient sleep

Arm Type

Experimental

Arm Description

Each participant will receive 4 nights of insufficient sleep.

Intervention Type

Behavioral

Intervention Name(s)

Insufficient sleep

Intervention Description

Four days of insufficient sleep

Primary Outcome Measure Information:

Title

Change in insulin sensitivity

Description

Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.

Time Frame

One week

Secondary Outcome Measure Information:

Title

Changes in macrovascular function

Description

Macrovascular function will be assessed with flow-mediated dilation

Time Frame

One week

Title

Changes in microvascular function

Description

Macrovascular function will be assessed with EndoPAT

Time Frame

One week

Title

Changes in cognitive abilities

Description

Cognitive computer tests performed during study

Time Frame

One week

Title

Changes in circadian rhythms

Description

Salivary dim-light melatonin offset will be assessed

Time Frame

One week

Title

Changes in metabolic tissue function

Description

Tissue biopsies will be performed

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Josiane L. Broussard, PhD

Phone

303-735-1923

josiane.broussard@colorado.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josiane L. Broussard, PhD

Organizational Affiliation

University of Colorado, Boulder

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Josiane Broussard

sleep.study@colorado.edu

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.ncbi.nlm.nih.gov/sites/myncbi/1JaM6qKzqsa5p/bibliography/45302103/public/?sort=date&direction=ascending

Description

Full list of publications

Learn more about this trial

Tissue-specific Effects of Insufficient Sleep

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