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

Type 1 Diabetes Clinical Trial

— VIGOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01834144
• Other study ID #: B2012:136
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Est. completion date: June 15, 2015

Study information

• Verified date: January 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 15, 2015
• Est. primary completion date: June 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Exercise Training

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	University of Ottawa	Ottawa	Ontario
Canada	Manitoba Institute of Child Health	WInnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Institute of Child Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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