Clinical trial NCT00724087: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sleep Deprivation
Insulin Resistance
Type 2 Diabetes
Keywords: short sleep duration
energy expenditure
insulin secretion
insulin action
lipid turnover
free fatty acids
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-29
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Total energy expenditure
timeFrame: during each bedtime intervention
Secondary outcomes:
measure: Physical activity related energy expenditure
timeFrame: during each bedtime intervention
measure: Total body insulin sensitivity
timeFrame: at the end of each bedtime intervention
measure: First and second phase insulin secretion
timeFrame: at the end of each bedtime intervention
measure: Endogenous glucose production
timeFrame: at the end of each bedtime intervention
measure: Glycerol turnover and free fatty acid concentration
timeFrame: at the end of each bedtime intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Plamen D Penev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: