The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial

NCT ID: NCT01834144

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-06-15

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Moderate intensity exercise

150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)

Group Type: ACTIVE_COMPARATOR

Exercise Training

Intervention Type: OTHER

Moderate + Vigorous Intensity Exercise

150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)

Group Type: ACTIVE_COMPARATOR

Exercise Training

Intervention Type: OTHER

Interventions

Exercise Training

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manitoba Institute of Child Health

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Jon McGavock

Associate Professor, Dept. Of Pediatrics and Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Manitoba Institute of Child Health

Winnipeg, Manitoba, Canada

McMaster University

Hamilton, Ontario, Canada

University of Ottawa

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

B2012:136

Identifier Type: -

Identifier Source: org_study_id