Type 1 DiabetesVIGORNCT01834144
The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial
A study testing Exercise Training in people with Type 1 Diabetes, run by University of Manitoba at 5 sites in Canada.
Trial summary
Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesCanada
- Study dates
- May 2013to 15 Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 15-45 years old
- Have lived with type 1 diabetes for at least 2 years
- HbA1c <9.9%
- Currently physically inactive (<150 minutes of self-reported structured physical activity per week)
- Undergone a resting ECG to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise
Who cannot join
- Have frequent and unpredictable hypoglycaemia
- Had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment
- Are currently participating in structured activity or sport-related activities
- Are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding
- Have conditions that would render physical activity contraindicated including: uncontrolled hypertension (BP>150mmHg systolic or >95mmHg diastolic in a sitting position); severe peripheral neuropathy; history of cardiovascular disease
- Have a cognitive deficit resulting in an inability to provide informed consent
- Currently taking beta blockers
- Currently taking atypical antipsychotics or corticosteroids
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 1N4
University of Alberta
Edmonton, Alberta, T6G 2R3
McMaster University
Hamilton, Ontario, L8S 4L8
University of Ottawa
Ottawa, Ontario, K1N 6N5
Manitoba Institute of Child Health
Winnipeg, Manitoba, R3E 3P4
About this study
Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).
Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.
- Conditions
- Type 1 Diabetes
- Being tested
- Exercise Training
- Keywords
- Type 1 Diabetes, Hypoglycaemia, Glycaemic variability, Vigorous Intensity Physical Activity, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity exercise | Active comparator | 150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness) Receives: Other: Exercise Training |
| Moderate + Vigorous Intensity Exercise | Active comparator | 150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness) Receives: Other: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor.
Measured: Measured at baseline, and 1, 8,16 and 52 weeks following randomization
Secondary outcomes (1)
Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome.
Measured: Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startMay 2013
- Primary completion15 Jun 2015
- Study completion15 Jun 2015
Why it stopped: Funding for the study was not renewed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834144
- Sponsor's protocol ID
- B2012:136
- Acronym
- VIGOR
- Status last verified
- Jan 2018
- First submitted
- 27 Mar 2013
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial
- ClinicalTrials.gov ID
- NCT01834144
- Acronym / sponsor ID
- VIGOR / B2012:136
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Hypoglycaemia, Glycaemic variability, Vigorous Intensity Physical Activity, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for the study was not renewed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Study start
- May 2013
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 15 Jun 2015 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).
Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity exercise | Active comparator | Other: Exercise Training150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness) |
| Moderate + Vigorous Intensity Exercise | Active comparator | Other: Exercise Training150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: 15-45 years old
- Have lived with type 1 diabetes for at least 2 years
- HbA1c <9.9%
- Currently physically inactive (<150 minutes of self-reported structured physical activity per week)
- Undergone a resting ECG to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise
Key exclusion criteria (8 listed)
- Have frequent and unpredictable hypoglycaemia
- Had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment
- Are currently participating in structured activity or sport-related activities
- Are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding
- Have conditions that would render physical activity contraindicated including: uncontrolled hypertension (BP>150mmHg systolic or >95mmHg diastolic in a sitting position); severe peripheral neuropathy; history of 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 |
|---|---|---|
| Exercise Training | Other | Moderate + Vigorous Intensity Exercise, Moderate intensity exercise |
Primary outcome
Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor.
Time frame: Measured at baseline, and 1, 8,16 and 52 weeks following randomization
1 secondary outcome
Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome.
Time frame: Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Type 1 Diabetes, run by University of Manitoba at 5 sites 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 5 inclusion and 8 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 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 20 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor. (time frame: Measured at baseline, and 1, 8,16 and 52 weeks following randomization). 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 20 Sep 2018.