Fitness and Sleep in People With Family History of Type 2 Diabetes.

September 4, 2013 updated by: University of Chicago

Sleep, Energy Metabolism and Diabetes Risk

Currently, it is not known if the amount of nighttime sleep has any effect on the overall physical fitness, and on how much energy do people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform activities of daily living. This study will test the hypothesis that individual differences in nighttime sleep duration are related to differences in the amount of energy used to perform activities of daily living and the overall level of physical fitness of the individual.

Study Overview

Status

Completed

Detailed Description

The study includes 2 weeks of monitoring of the participants' patterns of sleep and wakefulness at home. At the beginning of this period, all participants will undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal. At that time, all participants will also 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 at the beginning of the study and again 14 days later in order to measure the amount of energy that was used by them during this time. Participants will also wear small wristwatch-like activity monitors on their wrist and around their waist as they follow their usual everyday activities and sleep-wake schedules at home. The recordings from these monitors combined with daily sleep logs will be used to determine when the participants slept and when they were awake. On the last day of the study, the participants will undergo MRI measurements of the distribution of fat in their abdomen and complete a graded exercise test on a treadmill or stationary bicycle in order to determine what is the most strenuous level of exercise that they can perform. A medical doctor will supervise all study procedures that are done in the research laboratory.

Study Type

Observational

Enrollment (Actual)

30

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
        • The 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

Sampling Method

Non-Probability Sample

Study Population

Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes

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
  • for women: use of birth control pills
  • for women: 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

Cohorts and Interventions

Group / Cohort
Reduced sleep
Habitual sleep duration of less than 6 hours per night on most days of the week and total sleep of less than 43 hours per week.
Reference sleep
Habitual sleep duration between 7 and 8.5 hours per night on most days of the week and total sleep of at least 53 hours per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total energy expenditure
Time Frame: during a 2-week observation period
during a 2-week observation period

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal aerobic capacity
Time Frame: at the end of the observation period
at the end of the observation period
Amount and distribution of body fat
Time Frame: at the end of the observation period
at the end of the observation period
Physical activity related energy expenditure
Time Frame: during a 2-week observation period
during a 2-week observation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Plamen D Penev, MD, PhD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

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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