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

NCT ID: NCT00724087

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-03-31

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.

Conditions

Sleep; Sleep Deprivation; Insulin Resistance; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

5.5-hour bedtime

Group Type: EXPERIMENTAL

5.5-hour bedtime

Intervention Type: OTHER

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

8.5-hour bedtime

Group Type: EXPERIMENTAL

8.5-hour bedtime

Intervention Type: OTHER

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

Interventions

5.5-hour bedtime

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

Intervention Type: OTHER

8.5-hour bedtime

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Plamen D Penev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R01HL089637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16079A-S4

Identifier Type: -

Identifier Source: org_study_id