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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827239
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Prince Edward Island

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.


Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Insulin Sensitivity Glucose Metabolism Other: Activity/Moderate Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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
Other: Activity/Moderate Exercise
3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827239


Contacts
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Contact: Adam Johnston, PhD 902-620-5225 adjohnston@upei.ca
Contact: Travis Saunders, PhD 902-566-0641 trsaunders@upei.ca

Locations
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Canada, Prince Edward Island
University of Prince Edward Island Recruiting
Charlottetown, Prince Edward Island, Canada, C1A 4P3
Contact: Magdalena Mahlstedt, PhD    9026205089    mmahlstedt@upei.ca   
Principal Investigator: Adam Johnston, PhD         
Principal Investigator: Travis Saunders, PhD         
Sponsors and Collaborators
University of Prince Edward Island
Investigators
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Study Director: Magdalena Mahlstedt, PhD University of Prince Edward Island
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Responsible Party: University of Prince Edward Island
ClinicalTrials.gov Identifier: NCT03827239    
Other Study ID Numbers: 6007895
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases