- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724087
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.
September 4, 2013 updated by: University of Chicago
Sleep, Energy Metabolism and Diabetes Risk.
The use of energy from food changes when people sleep.
However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities.
This study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study participants will complete two 16-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart.
Bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5 hours per night during the other.
No daytime naps will be allowed.
Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack.
On weekdays all participants will engage in simulated "office work" in the sleep laboratory.
During the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the University of Chicago campus.
At the beginning of each inpatient stay, study participants will drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water.
Several urine samples will be collected before and after the participants drink the water and again 14 days later in order to measure the amount of energy that was used by them during this time.
At the end of each stay participants will also undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal, and will complete tests to determine how much insulin does their body produce in response to an intravenous glucose infusion and how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.
Study Type
Interventional
Enrollment (Actual)
12
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
- 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
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- regular sleep habits
- BMI 20 to 27 kg/m2
- at least one parent, sibling or grandparent with type 2 diabetes
- must exercise regularly
Exclusion Criteria:
- active smoker
- night or shift work
- have highly variable sleep habits
- have a hormonal disorder
- have a sleep disorder
- have an active medical problem
- women only: use of birth control pills
- women only: irregular menstrual periods or pregnancy
- use of medications/compounds that can disrupt sleep
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 5.5-hour bedtime
|
16 days with sleep allowed only during a 5.5-hour bedtime period at night
|
|
Experimental: 8.5-hour bedtime
|
16 days with sleep allowed only during a 8.5-hour bedtime period at night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total energy expenditure
Time Frame: during each bedtime intervention
|
during each bedtime intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical activity related energy expenditure
Time Frame: during each bedtime intervention
|
during each bedtime intervention
|
|
Total body insulin sensitivity
Time Frame: at the end of each bedtime intervention
|
at the end of each bedtime intervention
|
|
First and second phase insulin secretion
Time Frame: at the end of each bedtime intervention
|
at the end of each bedtime intervention
|
|
Endogenous glucose production
Time Frame: at the end of each bedtime intervention
|
at the end of each bedtime intervention
|
|
Glycerol turnover and free fatty acid concentration
Time Frame: at the end of each bedtime intervention
|
at the end of each bedtime intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Plamen D Penev, MD, PhD, University of Chicago
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
July 1, 2008
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 25, 2008
First Posted (Estimate)
July 29, 2008
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16079A-S4
- R01HL089637 (U.S. NIH Grant/Contract)
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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