Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.
Primary Purpose
Sleep, Sleep Deprivation, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5.5-hour bedtime
8.5-hour bedtime
Sponsored by
About this trial
This is an interventional basic science trial for Sleep focused on measuring short sleep duration, energy expenditure, insulin secretion, insulin action, lipid turnover, free fatty acids
Eligibility Criteria
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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
5.5-hour bedtime
8.5-hour bedtime
Arm Description
Outcomes
Primary Outcome Measures
Total energy expenditure
Secondary Outcome Measures
Physical activity related energy expenditure
Total body insulin sensitivity
First and second phase insulin secretion
Endogenous glucose production
Glycerol turnover and free fatty acid concentration
Full Information
NCT ID
NCT00724087
First Posted
July 25, 2008
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00724087
Brief Title
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.
Official Title
Sleep, Energy Metabolism and Diabetes Risk.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Deprivation, Insulin Resistance, Type 2 Diabetes
Keywords
short sleep duration, energy expenditure, insulin secretion, insulin action, lipid turnover, free fatty acids
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5.5-hour bedtime
Arm Type
Experimental
Arm Title
8.5-hour bedtime
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
5.5-hour bedtime
Intervention Description
16 days with sleep allowed only during a 5.5-hour bedtime period at night
Intervention Type
Other
Intervention Name(s)
8.5-hour bedtime
Intervention Description
16 days with sleep allowed only during a 8.5-hour bedtime period at night
Primary Outcome Measure Information:
Title
Total energy expenditure
Time Frame
during each bedtime intervention
Secondary Outcome Measure Information:
Title
Physical activity related energy expenditure
Time Frame
during each bedtime intervention
Title
Total body insulin sensitivity
Time Frame
at the end of each bedtime intervention
Title
First and second phase insulin secretion
Time Frame
at the end of each bedtime intervention
Title
Endogenous glucose production
Time Frame
at the end of each bedtime intervention
Title
Glycerol turnover and free fatty acid concentration
Time Frame
at the end of each bedtime intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Plamen D Penev, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.
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