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Sleep, Exercise and Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT03556410
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jill Kanaley, University of Missouri-Columbia

Brief Summary:
Insufficient or disrupted sleep, lack of physical activity and poor diet are linked with obesity and are now potential targets to combat obesity. Sleep related issues have become more important as people have been able to work, socialize, and use electronic devices outside of daylight hours. This has also altered how we eat and how we exercise. All of these factors can cause the body to not handle glucose (sugar) well resulting in insulin resistance. In time this could lead to type 2 diabetes.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: sleep Behavioral: exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sleep, Exercise and Insulin Sensitivity
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Placebo Comparator: sleep
Subject will undergo 5 days of shortened sleep and then 2 days of ad libitum sleep.
Behavioral: sleep
Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored.

Experimental: sleep+exercise
Subject will undergo 5 days of shortened sleep but also have 45 min of moderate exercise/day and then 2 days of ad libitum sleep
Behavioral: sleep
Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored.

Behavioral: exercise
Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored and 45 min of exercise will be required during the shortened sleep days .




Primary Outcome Measures :
  1. glucose tolerance [ Time Frame: 3 hour glucose before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep ]
    integrated area under the curve


Secondary Outcome Measures :
  1. insulin [ Time Frame: 3 hour insulin before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep ]
    integrated area under the curve

  2. FFA [ Time Frame: fasting values at the beginning of the OGTT ]
    fasting FFA concentrations



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight and obese men and women
  • BMI of 25-35 kg/m2
  • normally active (>5000 steps per day)
  • normal sleeping habits of 7-9 hours per night

Exclusion Criteria:

  • type 2 diabetics
  • diagnosed with cardiovascular disease
  • hypertensive
  • smokers
  • pregnant
  • taking lipid-lowering medications
  • have any recent changes in hormonal birth control
  • night shift workers or take regular daytime naps
  • on any medications known to impact metabolism, appetite, or sleep
  • have any allergies to milk and soy
  • sleep apnea or other sleep disorders
  • if the 7 days of sleep monitoring prior to sleep restriction period shows inconsistent sleep hours outside of 7-9 hours per night.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556410


Contacts
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Contact: Jay Porter, MS 7402857685 jwpp64@mail.missouri.edu
Contact: jill kanaley, PhD 573-882-2519 kanaleyj@missouri.edu

Locations
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United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65211
Contact: Jill Kanaley, PhD    573-882-2519    kanaleyj@missouri.edu   
Principal Investigator: Jill kanaley, PhD         
Sponsors and Collaborators
University of Missouri-Columbia

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Responsible Party: Jill Kanaley, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03556410     History of Changes
Other Study ID Numbers: Sleep and Exercise
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share data on request that will be deidentified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Kanaley, University of Missouri-Columbia:
Sleep
Obesity
Metabolic Syndrome
Physical Activity
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs