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The Effects of Altering Physical Activity on Cardiometabolic Health (PIA)

Primary Purpose

Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring insulin resistance, exercise, continuous glucose monitoring, blood flow, endothelial function

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Missouri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01879059

First Posted

January 24, 2012

Last Updated

January 4, 2016

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01879059

Brief Title

The Effects of Altering Physical Activity on Cardiometabolic Health

Acronym

PIA

Official Title

The Effects of Altering Physical Activity on Endothelial Function, Glycemic Control, and the Blood Flow Response to an Oral Glucose Tolerance Test.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Herein, we tested the hypothesis that an acute reduction in daily activity (from >10,000 to <5,000 steps/day) for 5 days in healthy individuals reduced meal-stimulated blood flow and if a 1 day return to activity improved this outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance

Keywords

insulin resistance, exercise, continuous glucose monitoring, blood flow, endothelial function

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Effects of Physical Inactivity on Post Prandial Blood Flow

Description

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Thyfault, PhD

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Missouri

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65211

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21716152

Citation

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.

Results Reference

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PubMed Identifier

21737826

Citation

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.

Results Reference

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The Effects of Altering Physical Activity on Cardiometabolic Health

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