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

Sedentary Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03827239
• Other study ID #: 6007895
• Status: Terminated
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: University of Prince Edward Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Glucose Metabolism
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
Canada	University of Prince Edward Island	Charlottetown	Prince Edward Island

Sponsors (1)

Lead Sponsor	Collaborator
University of Prince Edward Island

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
Primary	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).	Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
Primary	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.	Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
Primary	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.	Pre-prandial and 3-hours post test meal through study completion
Secondary	Immediate effects of short-term sedentary behaviour on cognitive function	Assessing cognitive abilities using the Stroop Test.	3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Secondary	Immediate effects of short-term sedentary behaviour on cognitive function	Assessing cognitive abilities using the Iowa Trail Making Test.	3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Secondary	Immediate effects of short-term sedentary behaviour on cognitive function	Assessing cognitive abilities using the Digit-Span test.	3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Secondary	Immediate effects of short-term sedentary behaviour on cognitive function	Assessing cognitive abilities using the N-back test.	3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Secondary	Immediate effects of short-term sedentary behaviour on cognitive function	Assessing cognitive abilities using the Flankers test.	3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Secondary	Gene expression levels in isolated PBMC populations	Determining changes in gene expression in pathways associated with RAGE signalling.	Pre-prandial and 3 hours post-prandial on on test days through study completion