Tissue-specific Effects of Insufficient Sleep

NCT ID: NCT03437681

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Sleep Blood Sugar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The project is a within-subject consecutive design examining 18 healthy individuals after baseline and after 4 nights of insufficient sleep.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Insufficient sleep

Each participant will receive 4 nights of insufficient sleep.

Group Type EXPERIMENTAL

Insufficient sleep

Intervention Type BEHAVIORAL

Four days of insufficient sleep

Interventions

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Insufficient sleep

Four days of insufficient sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josiane L. Broussard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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17-0533

Identifier Type: -

Identifier Source: org_study_id