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

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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

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE January 17, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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).
  • 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).
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
Official Title  ICMJE Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Sedentary Lifestyle
  • Insulin Sensitivity
  • Glucose Metabolism
Intervention  ICMJE Other: Activity/Moderate Exercise
3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes
Study Arms  ICMJE
  • 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
    Intervention: Other: Activity/Moderate Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • diabetes
  • kidney disease
  • liver disease
  • cardiovascular disease
  • cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Adam Johnston, PhD 902-620-5225 adjohnston@upei.ca
Contact: Travis Saunders, PhD 902-566-0641 trsaunders@upei.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827239
Other Study ID Numbers  ICMJE 6007895
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Prince Edward Island
Study Sponsor  ICMJE University of Prince Edward Island
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Magdalena Mahlstedt, PhD University of Prince Edward Island
PRS Account University of Prince Edward Island
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP