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

NCT03827239 | Terminated

• 1 other identifier: 6007895
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle; Insulin Sensitivity; Glucose Metabolism

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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)

• 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 Outcomes (6)

• Immediate effects of short-term sedentary behaviour on cognitive function

  3 hours post-activity (sedentary behaviour or exercise) on test days through study completion

• Immediate effects of short-term sedentary behaviour on cognitive function

  3 hours post-activity (sedentary behaviour or exercise) on test days through study completion

• Immediate effects of short-term sedentary behaviour on cognitive function

  3 hours post-activity (sedentary behaviour or exercise) on test days through study completion

• Immediate effects of short-term sedentary behaviour on cognitive function

  3 hours post-activity (sedentary behaviour or exercise) on test days through study completion

• Immediate effects of short-term sedentary behaviour on cognitive function

  3 hours post-activity (sedentary behaviour or exercise) on test days through study completion

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes

Other: Activity/Moderate Exercise

Interventions

Activity/Moderate Exercise OTHER

3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Prince Edward Island: lead

Study Sites (1)

University of Prince Edward Island

Charlottetown, Prince Edward Island, C1A 4P3, Canada

Location

MeSH Terms

Conditions

Sedentary Behavior; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Magdalena Mahlstedt, PhD

  University of Prince Edward Island

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 1, 2019
• Study Start: January 17, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 29, 2021

Record last verified: 2019-01

Locations

CA (1)