NCT03556410

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

May 23, 2018

Last Update Submit

January 26, 2021

Conditions

Keywords

SleepObesityMetabolic SyndromePhysical Activity

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 COMPARATOR

Subject will undergo 5 days of shortened sleep and then 2 days of ad libitum sleep.

Behavioral: sleep

sleep+exercise

EXPERIMENTAL

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: sleepBehavioral: exercise

Interventions

sleepBEHAVIORAL

Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored.

sleepsleep+exercise
exerciseBEHAVIORAL

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 .

sleep+exercise

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

ObesityMetabolic SyndromeMotor Activity

Interventions

SleepExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological Phenomena

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.

Locations