- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721019
Sleep Loss and Glucose 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 sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep.
However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent).
This study is being done to test the hypothesis that the carbohydrate metabolism of people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 10 days in comparison to when they have slept longer hours for 10 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study participants will complete two 10-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center scheduled at least 4 weeks apart.
Bedtime duration will be set at 5 hours per night during one of these stays and 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" while 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.
During the last two days of each inpatient stay in the laboratory, participants will undergo two different tests.
The first test will determine how much insulin does their body produce in response to an intravenous glucose infusion lasting several hours.
The second test will determine 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)
11
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
- no regular exercise habits
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: 8.5-hour bedtime
|
10 days with sleep allowed only during a 8.5-hour period at night
|
Experimental: 5-hour bedtime
|
10 days with sleep restricted only to a 5-hour bedtime period at night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total body insulin sensitivity
Time Frame: at the end of each bedtime intervention
|
at the end of each bedtime intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 concentrations
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 21, 2008
First Submitted That Met QC Criteria
July 21, 2008
First Posted (Estimate)
July 23, 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-S3
- 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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