Sedentary LifestyleNCT03827239
Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
A study testing Activity/Moderate Exercise in people with Sedentary Lifestyle and Insulin Sensitivity, run by University of Prince Edward Island at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Insulin Sensitivity, Glucose Metabolism
- What is being tested?
- Activity/Moderate Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI between 18-30 kg/m²
- non-smoker
Who cannot join
- pregnant
- diabetes
- kidney disease
- liver disease
- cardiovascular disease
- cancer
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Prince Edward Island
Charlottetown, Prince Edward Island, C1A 4P3
About this study
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
- Being tested
- Activity/Moderate Exercise
- Medical subject headings
- Sedentary Behavior, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity/Moderate ExerciseOther
3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Activity/Moderate Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-prandial and 3-hours post test meal through study completion
Secondary outcomes (6)
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Stroop Test.
Measured: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Iowa Trail Making Test.
Measured: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Digit-Span test.
Measured: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the N-back test.
Measured: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Immediate effects of short-term sedentary behaviour on cognitive function
Assessing cognitive abilities using the Flankers test.
Measured: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
Gene expression levels in isolated PBMC populations
Determining changes in gene expression in pathways associated with RAGE signalling.
Measured: Pre-prandial and 3 hours post-prandial on on test days through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start17 Jan 2019
- Primary completion31 Oct 2019
- Study completion31 Dec 2019
Why it stopped: Lack of funding caused us to cancel the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena Mahlstedt, PhD, Study director, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827239
- Sponsor's protocol ID
- 6007895
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT03827239
- Acronym / sponsor ID
- 6007895
- Conditions
- Sedentary Lifestyle, Insulin Sensitivity, Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding caused us to cancel the study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Activity/Moderate ExerciseWill disrupt their sedentary time with 3 minute exercise sessions every 30 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- BMI between 18-30 kg/m²
- non-smoker
Key exclusion criteria (6 listed)
- pregnant
- diabetes
- kidney disease
- liver disease
- cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity/Moderate Exercise3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes | Other | Intervention |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
Gene expression levels in isolated PBMC populations
Time frame: Pre-prandial and 3 hours post-prandial on on test days through study completion
Results and safety
The study was stopped early (reason given: Lack of funding caused us to cancel the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Mahlstedt, PhD study director
University of Prince Edward Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity/Moderate Exercise in people with Sedentary Lifestyle and Insulin Sensitivity, run by University of Prince Edward Island at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding caused us to cancel the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin levels (time frame: Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.