Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00724087

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Sleep Deprivation Insulin Resistance Type 2 Diabetes	Other: 5.5-hour bedtime Other: 8.5-hour bedtime	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Sleep, Energy Metabolism and Diabetes Risk.

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5.5-hour bedtime	Other: 5.5-hour bedtime 16 days with sleep allowed only during a 5.5-hour bedtime period at night
Experimental: 8.5-hour bedtime	Other: 8.5-hour bedtime 16 days with sleep allowed only during a 8.5-hour bedtime period at night

Arm

Intervention/Treatment

Experimental: 5.5-hour bedtime

Other: 5.5-hour bedtime

16 days with sleep allowed only during a 5.5-hour bedtime period at night

Experimental: 8.5-hour bedtime

Other: 8.5-hour bedtime

16 days with sleep allowed only during a 8.5-hour bedtime period at night

Outcome Measures

Primary Outcome Measures

Total energy expenditure [during each bedtime intervention]

Secondary Outcome Measures

Physical activity related energy expenditure [during each bedtime intervention]
Total body insulin sensitivity [at the end of each bedtime intervention]
First and second phase insulin secretion [at the end of each bedtime intervention]
Endogenous glucose production [at the end of each bedtime intervention]
Glycerol turnover and free fatty acid concentration [at the end of each bedtime intervention]