Low Intensity Physical Activity During Sitting on Glycemic Control and Vascular Function in Obese Individuals

March 23, 2020 updated by: Jill Kanaley, University of Missouri-Columbia

The Impact of Low Intensity Physical Activity During Sitting on Glycemic Control and Vascular Function in Obese Individuals

Prolonged sitting is a common behavior in contemporary humans. In epidemiological studies, increased sitting time has been associated with increased risk for cardiovascular disease and all-cause mortality. Recent research has also shown that interrupting sitting time with standing prevents the poorer glycemic control. However, studies are lacking which evaluate the impact of low intensity physical activity during prolonged sitting on vascular function. Whether low intensity physical activity can increase blood flow substantially and prevent impairment in vascular function and glycemic control is unknown.

The purpose of the present study is to evaluate whether increased blood flow during sitting via low intensity physical activity (fidgetting) prevents the impairment in vascular function and poorer glycemic control associated with prolonged sitting.

Study Overview

Status

Completed

Detailed Description

Experimental Design: Twenty obese subjects with metabolic syndrome will complete 2 study days with measures vascular function and glycemic control. On one study day, the subjects will sit quietly for 3 hours and on the second study day subjects will sit quietly for 3 hours and simultaneously move their legs using fidgetting.

VISIT 1: All visits will be in Gwynn Hall. On this visit subjects will be consented in the following manner: a review of the inclusion/exclusion criteria and discussion of the informed consent form including an oral explanation of the study purpose, protocol, and potential risks and benefits. Potential subjects will be given time to read the consent form and ask questions of the study personnel. After signing the informed consent, the popliteal artery will be imaged by Doppler ultrasound to ensure that the subject is a candidate for the study. Body composition will be measured and waist measurements will be made. Questionnaires will be filled out. Subjects will be asked to fill out a one day food record on the day prior to each study visit.

VISIT 2 and 3: Upon arrival to the laboratory, subjects will be asked to use the bathroom and height and weight measurements will be taken. An IV will be placed in a forearm vein. Subjects will then be asked to lie down and they will be instrumented for baseline assessment of blood pressure and flow-mediated dilation in the popliteal artery.

Energy expenditure (EE): A ParvoMedics TrueOne2400 metabolic measurement system (Sandy Lake, UT) will be used to measure EE. The EE measurement will occur throughout the sitting period on both study visits. During the measures, a mask will be placed on their face to collect their expired air. The air will be analyzed for O2 and CO2 content. The participants will be able to breathe room air normally during the procedure. This measurement will be made prior to ingesting the glucose and periodically throughout the sitting period.

After baseline assessments, the subject will be asked to drink a 75 g glucose drink. On one occasion, subjects will then sit in a comfortable chair with minimal movement. On the second study day, subjects will sit comfortably in a chair but will continuously move their legs by fidgetting. Subjects will be allowed to move their arms (e.g., use computer or read) although not vigorously. The rationale for maintaining activity in the legs is to increase muscle blood flow and thus increase shear stress. The subject will have access to a bathroom using a wheelchair if needed. Every hour, 3 assessments of blood pressure and leg blood flow will be made while the subject remains in the sitting position. After the 4-hour sitting period, subjects will lie down again for post-sitting assessment blood pressure and flow-mediated dilation.

Following the consumption of the glucose, a small blood sample will be taken every ½ hour for 3 hours. These samples will be used to measure glucose, insulin, glucagon, and c-peptide.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese males and females with metabolic syndrome, aged 20-60 years old.

According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met:

  • waist circumference over 40 inches (men) or 35 inches (women),
  • blood pressure over 130/85 mmHg,
  • fasting triglyceride (TG) level over 150 mg/dl,
  • fasting high-density lipoprotein (HDL) level less than 40 mg/dl (men) or 50 mg/dl (women)
  • fasting blood sugar over 100 mg/dl.

Exclusion Criteria:

  1. they smoke
  2. they have any known cardiovascular, pulmonary or metabolic disease
  3. have type 2 diabetes
  4. if good quality Doppler ultrasound image of their arteries cannot be obtained and/or evidence of plaque.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucose and Fidgetting
75 g of glucose will be given at the beginning of the study day (days one with glucose+fidgeting )
Glucose
low intensity physical activity (fidgetting)
Other Names:
  • low intensity physical activity
Placebo Comparator: Fidgetting
Subjects will fidget their legs in an up and down motion for 2.5 min on and then 2.5 min off for the duration of the study.
low intensity physical activity (fidgetting)
Other Names:
  • low intensity physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose tolerance
Time Frame: 3 hr
glucose area under the curve
3 hr
flow mediated dilation
Time Frame: every 30 min over 3 hr
flow
every 30 min over 3 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

January 20, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Fidget

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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