NCT01879059

Brief Summary

The effects of physical inactivity on variations in blood glucose and vascular health are not fully understood. The purpose of this study is to determine if an acute transition from physical activity to inactivity alters vascular health. Specifically, the investigators wish to examine in healthy, lean physically active individuals (obtaining greater than 10,000 steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter blood flow following a meal a marker of vascular health. Furthermore, the investigators wish to examine if a one day return to physical activity (obtaining \>10,000 steps/day) can restore the detrimental effects on blood flow following a meal.

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

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

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

January 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2016

Completed
Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.6 years

First QC Date

January 24, 2012

Results QC Date

October 14, 2014

Last Update Submit

January 4, 2016

Conditions

Insulin Resistance

Keywords

insulin resistanceexercisecontinuous glucose monitoringblood flowendothelial function

Outcome Measures

Primary Outcomes (1)

  • Effects of Physical Inactivity on Post Prandial Blood Flow

    There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.

    10 days

Study Arms (1)

Exercise

EXPERIMENTAL

5 days of inactivity followed by a 1 day return to physical activity

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

short period of inactivity (5 days) followed by a return to physical activity (1 day)

Exercise

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: less than 30 kg/m2
  • Physically active: exercise greater than 60mins per week

You may not qualify if:

  • smoking
  • type 2 diabetes
  • Underlying conditions that limit ability to exercise safely
  • Recent weight gain or loss(\> 5% of body weight in 3 months)
  • Recent (\< 3 mo) changes in medication use or dose
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (2)

  • Mikus CR, Oberlin DJ, Libla JL, Taylor AM, Booth FW, Thyfault JP. Lowering physical activity impairs glycemic control in healthy volunteers. Med Sci Sports Exerc. 2012 Feb;44(2):225-31. doi: 10.1249/MSS.0b013e31822ac0c0.

    PMID: 21716152BACKGROUND

  • Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.

    PMID: 21737826BACKGROUND

MeSH Terms

Conditions

Insulin ResistanceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
John P. Thyfault, PhD
Organization
University of Kansas Medical Center
jthyfault@kumc.edu
913-588-1790

Study Officials

  • John P Thyfault, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

June 17, 2013

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 8, 2016

Results First Posted

February 8, 2016

Record last verified: 2016-01

Locations

US(1)