Clinical trial NCT01834144: The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial
Official title: The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Hypoglycaemia
Glycaemic variability
Vigorous Intensity Physical Activity
Continuous Glucose Monitoring
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Institute of Child Health
First posted: 2013-04-17
Enrollment: 4
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: Measured at baseline, and 1, 8,16 and 52 weeks following randomization
Secondary outcomes:
measure: 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.
timeFrame: Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: WInnipeg
country: Canada
facility: Manitoba Institute of Child Health
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References: