- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915707
Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk
September 4, 2013 updated by: University of Chicago
This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
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
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
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 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Normal weight
- Healthy
- Normal sleep times
Exclusion Criteria:
- Sleep disorders
- Overweight
- Diabetes
- Other health conditions
- Excessive caffeine and alcohol intake
- Smoking
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
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Baseline
Subjects are tested under normal sleep conditions for carbohydrate metabolism and appetite regulation.
|
Subjects are allowed time in bed for sleep as their usual time at home.
|
|
Experimental: Sleep restriction
Subjects are tested under sleep restriction for carbohydrate metabolism and appetite regulation.
|
Subjects sleep is reduced to 4.5 hours in bed for 4 nights.
|
|
Experimental: Reduced sleep quality
Subjects are tested under a poor sleep quality condition for carbohydrate metabolism and appetite regulation.
|
Subjects sleep quality is reduced for 4 nights.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2007
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
June 3, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 8, 2009
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14916B
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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