NCT03583268

Brief Summary

Over 300, 000 youth and young adults across Canada are living with Type 1 Diabetes (T1D) which is considered the most common endocrine condition. Physical activity offers numerous health benefits however the majority of persons living with T1D are physically inactive, primarily due to fear of low blood sugar (hypoglycemia). This fear of hypoglycemia continues to exist for physically active persons with T1D as no established physical activity guidelines exist. Several acute studies have used high intensity interval training as a way to reduce the risk of hypoglycemia as it has the ability to activate fight or flight hormones which can raise blood sugar; however the intensity needed to elicit this response is unknown. The purpose of this project is to determine the acute effects of varying exercise intensities on the time spent in a low blood sugar range in 10 sedentary (VIGOR acute sedentary) and 16 physically active (VIGOR acute trained) individuals with T1D. Each participant will complete a maximal exercise test prior to the exercise sessions. Sedentary participants will complete 45 minutes of continuous moderate intensity exercise at 45-55% heart rate reserve (HRR) and three high intensity interval sessions with six one minute burst of high intensity at 70%, 80%, or 90% of HRR every four minutes. Active participants will complete 45 minutes of moderate intensity exercise at 45-55% of HRR and one high intensity interval session at 90% of HRR with intervals spaced every two minutes. The investigators will track the blood sugar response to exercise using a device called a continuous glucose monitor (CGM) which records blood sugar every five minutes over a period of six days. The CGM will help determine which exercise intensity does a better job at reducing the time spent in a low blood sugar range. The information gained through this study will help individuals with T1D remain active without fear of low blood sugar and provide guidelines for professionals working with this population. Adding high intensity bursts at 80% and 90% of maximum aerobic capacity (active participants) or heart rate reserve (sedentary participants) to a moderate intensity exercise session will significantly reduce the amount of time spent in a low blood sugar range in sedentary and active persons with T1D compared to moderate intensity exercise alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

March 18, 2015

Last Update Submit

June 27, 2018

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesPhysical activityHypoglycemiaGlucose variability

Outcome Measures

Primary Outcomes (1)

  • Percent time spent </= 3.9 mmol/L as measured by continuous glucose monitor

    The time spent \</= 3.9 mmol/L is measured through the continuous glucose monitor and is represented as a percentage.

    12 hours post exercise (6:00 PM to 6:00 AM)

Secondary Outcomes (2)

  • Mean absolute glucose change (MAG-mmol/L/h) as measured by continuous glucose monitor

    12 hours post exercise (6:00 PM to 6:00 AM)

  • Continuous overall net glycemic action (CONGA-mmol/L) as measured by continuous glucose monitor

    12 hours post exercise (6:00 PM to 6:00 AM)

Other Outcomes (3)

  • Cortisol

    two hours post exercise

  • Growth hormone

    two hours post exercise

  • Muscle mass as assessed by DEXA

    Baseline appointment ~20 minutes

Study Arms (4)

Moderate Intensity Exercise Alone

ACTIVE COMPARATOR

45 minutes of moderate intensity exercise at 45-55% of maximum aerobic capacity (active participants) or heart rate reserve (sedentary participants) used as a control condition. Participants will consume a glucerna bar at 10pm following this session.

Other: Exercise

70% Session

EXPERIMENTAL

45 minutes of moderate intensity exercise interspersed with one minute bouts at 70% heart rate reserve every 4 minutes. Note: this session is not included for the active participants. Participants will consume a glucerna bar at 10pm following this session.

Other: Exercise

80% Session

EXPERIMENTAL

45 minutes of moderate intensity exercise interspersed with one minute bouts at 80% of heart rate reserve every 4 minutes. Note: this session is not included for the active participants. Participants will consume a glucerna bar at 10pm following this session.

Other: Exercise

90% Session

EXPERIMENTAL

45 minutes of moderate intensity exercise interspersed with one minute bouts at 90% of maximum aerobic capacity (active participants every two minutes) or heart rate reserve (sedentary participants every 4 minutes). Participants will consume a glucerna bar at 10pm following this session.

Other: Exercise

Interventions

ExerciseOTHER

The intervention will be the different high intensity sessions. Time spent in hypoglycemia and glucose variability will be compared as follows: 70% vs. moderate, 80% vs. moderate, and 90% vs. moderate to see if high intensity is protective against hypoglycemia and provides lower glucose variability levels.

70% Session80% Session90% SessionModerate Intensity Exercise Alone

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Persons with type 1 diabetes
  • Hemoglobin A1c \<9.9%
  • Diabetes duration \>/= 2 years
  • Sedentary Participants: participate in \<150 minutes of moderate to vigorous physical activity per week
  • Active Participants: regular performance of vigorous physical activity \>3 times/week for over one year. Display a maximal oxygen uptake that is at least 40.9 ml/kg/min for females, and 49.3 ml/kg/min for males.

You may not qualify if:

  • HbA1c ≥9.9% as the lack of compliance with insulin suggests they may not be able to comply with the prescribed exercise requirements
  • Have frequent and unpredictable hypoglycemia as they will be at a greater risk of serious hypoglycemic events
  • Had a change in insulin management strategy, including adoption of a pump within two months of enrolment or switching back to multiple daily injections in the last two months, as they may be at risk for a hypoglycemic event due to the novel insulin management approach
  • Have conditions that would render vigorous intensity activity contraindicated including: uncontrolled hypertension: BP \>150 mm Hg systolic or \>95 mm Hg diastolic in a sitting position; severe peripheral neuropathy; or history of cardiovascular disease
  • Cognitive deficit resulting in an inability to provide informed consent
  • Are currently taking beta-blockers as this would limit the ability to achieve target heart rates within the prescribed range
  • Are currently being treated with medications (other than insulin) that alter glucose metabolism (i.e. atypical antipsychotics, corticosteroids)
  • Are women who are pregnant, breastfeeding, or planning to get pregnant
  • Have a job or profession that involves shift work (working during the night time, and being asleep during the daytime, as this alters glucose levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor ActivityHypoglycemia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jonathan McGavock, PhD

    University of Manitoba; Children's Hospital Research Institute of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 18, 2015

First Posted

July 11, 2018

Study Start

May 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 11, 2018

Record last verified: 2018-06

Locations

CA(1)