Back to resultsInvestigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
Primary Purpose
Sedentary Lifestyle, Insulin Sensitivity, Glucose Metabolism
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Activity/Moderate Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary Lifestyle
Eligibility Criteria
Inclusion Criteria:
- healthy
- BMI between 18-30 kg/m²
- non-smoker
Exclusion Criteria:
- pregnant
- diabetes
- kidney disease
- liver disease
- cardiovascular disease
- cancer
Sites / Locations
- University of Prince Edward Island
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes
Outcomes
Primary Outcome Measures
Change in Insulin levels
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).
Change in concentration of C-peptide
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).
Changes in blood glucose levels
Blood glucose levels will be determined at pre-prandial baseline and over the following 3-hour testing period using hand-held blood glucose meters.
Change in metabolomic response to a test meal
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.
Secondary Outcome Measures
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Stroop Test.
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Iowa Trail Making Test.
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Digit-Span test.
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the N-back test.
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Flankers test.
Gene expression levels in isolated PBMC populations
Determining changes in gene expression in pathways associated with RAGE signalling.
Full Information
NCT ID
NCT03827239
First Posted
January 22, 2019
Last Updated
January 26, 2021
Sponsor
University of Prince Edward Island
1. Study Identification
Unique Protocol Identification Number
NCT03827239
Brief Title
Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
Official Title
Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding caused us to cancel the study.
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Prince Edward Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Insulin Sensitivity, Glucose Metabolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes
Intervention Type
Other
Intervention Name(s)
Activity/Moderate Exercise
Intervention Description
3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes
Primary Outcome Measure Information:
Title
Change in Insulin levels
Description
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).
Time Frame
Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
Title
Change in concentration of C-peptide
Description
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).
Time Frame
Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
Title
Changes in blood glucose levels
Description
Blood glucose levels will be determined at pre-prandial baseline and over the following 3-hour testing period using hand-held blood glucose meters.
Time Frame
Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
Title
Change in metabolomic response to a test meal
Description
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.
Time Frame
Pre-prandial and 3-hours post test meal through study completion
Secondary Outcome Measure Information:
Title
Immediate effects of short-term sedentary behaviour on cognitive function
Description
Assessing cognitive abilities using the Stroop Test.
Time Frame
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Title
Immediate effects of short-term sedentary behaviour on cognitive function
Description
Assessing cognitive abilities using the Iowa Trail Making Test.
Time Frame
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Title
Immediate effects of short-term sedentary behaviour on cognitive function
Description
Assessing cognitive abilities using the Digit-Span test.
Time Frame
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Title
Immediate effects of short-term sedentary behaviour on cognitive function
Description
Assessing cognitive abilities using the N-back test.
Time Frame
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Title
Immediate effects of short-term sedentary behaviour on cognitive function
Description
Assessing cognitive abilities using the Flankers test.
Time Frame
3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Title
Gene expression levels in isolated PBMC populations
Description
Determining changes in gene expression in pathways associated with RAGE signalling.
Time Frame
Pre-prandial and 3 hours post-prandial on on test days through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
BMI between 18-30 kg/m²
non-smoker
Exclusion Criteria:
pregnant
diabetes
kidney disease
liver disease
cardiovascular disease
cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Mahlstedt, PhD
Organizational Affiliation
University of Prince Edward Island
Official's Role
Study Director
Facility Information:
Facility Name
University of Prince Edward Island
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 4P3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
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