Sleep, Exercise and Insulin Sensitivity
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2018
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedJanuary 28, 2021
January 1, 2021
2.2 years
May 23, 2018
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glucose tolerance
integrated area under the curve
3 hour glucose before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep
Secondary Outcomes (2)
insulin
3 hour insulin before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep
FFA
fasting values at the beginning of the OGTT
Study Arms (2)
sleep
PLACEBO COMPARATORSubject will undergo 5 days of shortened sleep and then 2 days of ad libitum sleep.
sleep+exercise
EXPERIMENTALSubject will undergo 5 days of shortened sleep but also have 45 min of moderate exercise/day and then 2 days of ad libitum sleep
Interventions
Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored.
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 .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri
Columbia, Missouri, 65211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2018
First Posted
June 14, 2018
Study Start
October 1, 2018
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
January 28, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
We will share data on request that will be deidentified.