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

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 Overview

• Status: Terminated
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2R3
      • University of Alberta
  • Manitoba
    • WInnipeg, Manitoba, Canada, R3E 3P4
      • Manitoba Institute of Child Health
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University
    • Ottawa, Ontario, Canada, K1N 6N5
      • University of Ottawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Moderate intensity exercise; 150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)	Other: Exercise Training
Active Comparator: Moderate + Vigorous Intensity Exercise; 150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)	Other: Exercise Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 at baseline, and 1, 8,16 and 52 weeks following randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
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 at baseline, and 1, 8, 16 and 52 weeks following randomization

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Manitoba Institute of Child Health

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 15, 2015
• Study Completion (Actual): June 15, 2015

Study Registration Dates

• First Submitted: March 27, 2013
• First Submitted That Met QC Criteria: April 13, 2013
• First Posted (Estimate): April 17, 2013

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Type 1 Diabetes; Hypoglycaemia; Glycaemic variability; Vigorous Intensity Physical Activity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: B2012:136