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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00721084
First received: July 21, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition
Sleep
Physical Fitness
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Sleep, Energy Metabolism and Diabetes Risk

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Total energy expenditure [ Time Frame: during a 2-week observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal aerobic capacity [ Time Frame: at the end of the observation period ] [ Designated as safety issue: No ]
  • Amount and distribution of body fat [ Time Frame: at the end of the observation period ] [ Designated as safety issue: No ]
  • Physical activity related energy expenditure [ Time Frame: during a 2-week observation period ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721084

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Plamen D Penev, MD, PhD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00721084     History of Changes
Other Study ID Numbers: 16079A-S1, R01HL089637
Study First Received: July 21, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
short sleep duration
maximal aerobic capacity
body fat
visceral adiposity
activity-related energy expenditure
energy metabolism

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014