- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827239
Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 4P3
- University of Prince Edward Island
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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Experimental: Intervention
Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes
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3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Insulin levels
Time Frame: Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
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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).
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Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
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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
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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).
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Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
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Changes in blood glucose levels
Time Frame: Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
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Blood glucose levels will be determined at pre-prandial baseline and over the following 3-hour testing period using hand-held blood glucose meters.
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Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
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Change in metabolomic response to a test meal
Time Frame: Pre-prandial and 3-hours post test meal through study completion
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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.
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Pre-prandial and 3-hours post test meal through study completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Assessing cognitive abilities using the Stroop Test.
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3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
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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
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Assessing cognitive abilities using the Iowa Trail Making Test.
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3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
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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
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Assessing cognitive abilities using the Digit-Span test.
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3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
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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
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Assessing cognitive abilities using the N-back test.
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3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
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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
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Assessing cognitive abilities using the Flankers test.
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3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
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Gene expression levels in isolated PBMC populations
Time Frame: Pre-prandial and 3 hours post-prandial on on test days through study completion
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Determining changes in gene expression in pathways associated with RAGE signalling.
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Pre-prandial and 3 hours post-prandial on on test days through study completion
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Collaborators and Investigators
Investigators
- Study Director: Magdalena Mahlstedt, PhD, University of Prince Edward Island
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6007895
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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