Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity

January 26, 2021 updated by: University of Prince Edward Island

Individuals with pre-diabetes or diabetes would benefit from low impact methods that would improve their insulin sensitivity and aid in maintaining glucose homeostasis. Physical activity helps the body decrease its insulin resistance and burn excess sugar. Many diabetics also suffer from obesity and specific forms or durations of physical exercise may not be viable options for these individuals. Determining whether short bursts of moderate exercise improve blood glucose levels in healthy humans may identify a further method for diabetics to improve their glucose homeostasis.

The aim of this study is to determine the most effective moderate exercise that can be completed in 3 minutes and its effectiveness on improving glucose handling, in response to a single day of standardized high-fat and high-carbohydrate feeding in comparison to periods of prolonged sitting.

Study Overview

Study Type

Interventional

Enrollment (Actual)

6

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

    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 4P3
        • University of Prince Edward Island

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy
  • BMI between 18-30 kg/m²
  • non-smoker

Exclusion Criteria:

  • pregnant
  • diabetes
  • kidney disease
  • liver disease
  • cardiovascular disease
  • cancer

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
No Intervention: Control
No intervention. Study participants will be seated during the entire sedentary 3-hour time period and wheeled to phlebotomy (and exercise) stations when required. During the sedentary period, participants will eat the food according to the study protocol and be seated at desks and allowed to read and use computers.
Experimental: Intervention
Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes
3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insulin levels
Time Frame: Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
The change in blood insulin levels from baseline (12 hours fasted) to 3-hours post-prandial will be determined from blood serum using a human metabolic hormone multiplex panel (Luminex xMAP technology).
Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
Change in concentration of C-peptide
Time Frame: Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
The change in blood C-peptide levels from baseline (12 hours fasted) to 3-hours post-prandial will be determined from blood serum using a human metabolic hormone multiplex panel (Luminex xMAP technology).
Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
Changes in blood glucose levels
Time Frame: Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
Blood glucose levels will be determined at pre-prandial baseline and over the following 3-hour testing period using hand-held blood glucose meters.
Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
Change in metabolomic response to a test meal
Time Frame: Pre-prandial and 3-hours post test meal through study completion
Targeted metabolomics analysis of approximately 139 metabolites in blood serum by LC-MS/MS to generate a metabolomic profile in response to a high-fat and high-carbohydrate test meal. Metabolites to be determined are categorized as biogenic amines, amino acids, histidines, carboxylic acids, acylcarnitines, glycerophospholipids and organic acids.
Pre-prandial and 3-hours post test meal through study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate effects of short-term sedentary behaviour on cognitive function
Time Frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Assessing cognitive abilities using the Stroop Test.
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Time Frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Assessing cognitive abilities using the Iowa Trail Making Test.
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Time Frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Assessing cognitive abilities using the Digit-Span test.
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Time Frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Assessing cognitive abilities using the N-back test.
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Time Frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Assessing cognitive abilities using the Flankers test.
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Gene expression levels in isolated PBMC populations
Time Frame: Pre-prandial and 3 hours post-prandial on on test days through study completion
Determining changes in gene expression in pathways associated with RAGE signalling.
Pre-prandial and 3 hours post-prandial on on test days through study completion

Collaborators and Investigators

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

Investigators

  • Study Director: Magdalena Mahlstedt, PhD, University of Prince Edward Island

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)

January 17, 2019

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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