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

NCT01834144 | Terminated Results DMC

• 1 other identifier: B2012:136
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

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

Keywords

Type 1 Diabetes; Hypoglycaemia; Glycaemic variability; Vigorous Intensity Physical Activity; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 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 at baseline, and 1, 8, 16 and 52 weeks following randomization

Study Arms (2)

Moderate intensity exercise

ACTIVE COMPARATOR

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

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)

Other: Exercise Training

Interventions

Exercise Training OTHER

Moderate + Vigorous Intensity Exercise; Moderate intensity exercise

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Institute of Child Health: collaborator

Study Sites (5)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Manitoba Institute of Child Health

Winnipeg, Manitoba, R3E 3P4, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Jonathan McGavock
• Organization: University of Manitoba

jmcgavock@chrim.ca

204-480-1359

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept. Of Pediatrics and Child Health

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 17, 2013
• Study Start: May 1, 2013
• Primary Completion: June 15, 2015
• Study Completion: June 15, 2015
• Last Updated: September 20, 2018
• Results First Posted: September 20, 2018

Record last verified: 2018-01

Locations

CA (5)