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

NCT ID: NCT00721019

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Sleep Deprivation Insulin Resistance Type 2 Diabetes

Keywords

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short sleep duration glucose clamp technique insulin secretion insulin action lipid turnover free fatty acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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5-hour bedtime

Group Type EXPERIMENTAL

5-hour bedtime

Intervention Type OTHER

10 days with sleep restricted only to a 5-hour bedtime period at night

8.5-hour bedtime

Group Type EXPERIMENTAL

8.5-hour bedtimes

Intervention Type OTHER

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

Interventions

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5-hour bedtime

10 days with sleep restricted only to a 5-hour bedtime period at night

Intervention Type OTHER

8.5-hour bedtimes

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Plamen D Penev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL089637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16079A-S3

Identifier Type: -

Identifier Source: org_study_id