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

Sponsor
University of Prince Edward Island (Other)
Overall Status
Terminated
CT.gov ID
NCT03827239
Collaborator
(none)
6
1
2
11.4
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Activity/Moderate Exercise
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 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 :
Jan 17, 2019
Actual Primary Completion Date :
Oct 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Insulin levels [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy

  • BMI between 18-30 kg/m²

  • non-smoker

Exclusion Criteria:
  • pregnant

  • diabetes

  • kidney disease

  • liver disease

  • cardiovascular disease

  • cancer

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Prince Edward Island Charlottetown Prince Edward Island Canada C1A 4P3

Sponsors and Collaborators

  • University of Prince Edward Island

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Prince Edward Island
ClinicalTrials.gov Identifier:
NCT03827239
Other Study ID Numbers:
  • 6007895
First Posted:
Feb 1, 2019
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2021