Status:
TERMINATED
The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Manitoba Institute of Child Health
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
15-45 years
Phase:
NA
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. De...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01834144
Start Date
May 1 2013
End Date
June 15 2015
Last Update
September 20 2018
Active Locations (5)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
3
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada, R3E 3P4
4
McMaster University
Hamilton, Ontario, Canada, L8S 4L8