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

Type 2 Diabetes Clinical Trial

Official title:

Sleep, Energy Metabolism and Diabetes Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721084
• Other study ID #: 16079A-S1
• Secondary ID: R01HL089637
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: September 4, 2013
• Start date: July 2008
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Physical Fitness
• Sleep
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total energy expenditure		during a 2-week observation period	No
Secondary	Maximal aerobic capacity		at the end of the observation period	No
Secondary	Amount and distribution of body fat		at the end of the observation period	No
Secondary	Physical activity related energy expenditure		during a 2-week observation period	No