Clinical trial NCT03583268: Determining the Appropriate Intensity of Exercise to Prevent Post-exercise Hypoglycemia in Persons Living With T1D
Official title: Determining the Appropriate Intensity of Vigorous Intensity Exercise to Prevent Post-exercise Hypoglycemia in Persons Living With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Physical activity
Hypoglycemia
Glucose variability
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2018-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: Sedentary Arm: This portion of the study is complete. 10 participants completed the study in its entirety. Maximal exercise testing utilized a Parvomedics Metabolic cart to analyze oxygen consumption in ml/kg/min and maximum heart rate. Results from this test were used to estimate intensity using heart rate for the exercise sessions. Prior to each exercise session, participants arrived at 4:00 PM ate a Glucerna bar (to prevent drastic falls in glycemia with exercise) and had an IV inserted. A total of six blood samples were taken at each session at the following timepoints: (1) 0 mins-baseline, (2) 10 mins- end of warm up, (3) 35 mins-end of intervals, (4) 45 mins-end of exercise, (5) 75 mins-mid recovery, and (6) 105 mins-end of exercise. Each blood draw was sampled for glucose, cortisol, and growth hormone. Before exercise, blood glucose was measured on a handheld glucometer. If blood glucose was \<5.7 mmol/L glucose was administered via Dex4 tablets. Exercise did not begin until blood glucose was at least 5.7 mmol/L. If blood glucose was greater than 16.7 mmol/L but less than 20.0 mmol/L ketones were tested on a urine ketone strip. If ketones were negative or trace exercise began.

The first exercise session was 45 minutes of moderate intensity exercise at 45-55% of heart rate reserve (HRR). The intensity determined from this session (speed and incline) was used as the recovery intensity for the high intensity sessions. The high intensity sessions were allocated in a random order from www.random.org where 1=70%, 2=80%, and 3=90%. Each high intensity session started with 10 minutes of moderate intensity exercise (at the same speed and incline from the first session) and six one minute bursts of high intensity every four minutes followed by a 10 minute cool down.

Because of the small sample size and non-normal glucose profiles, data was analyzed using a Friedman analysis of variance (non-parametric test).

Active Arm: This portion is still recruiting participants. The procedures for this experiment are very similar to the sedentary component. Blood glucose targets prior to exercise are the same however no blood samples will be taken. Participants will arrive at the lab for 4:30 PM and eat a Glucerna bar (to avoid drastic falls in glycemia with exercise). The two exercise sessions, moderate and 90%, will be allocated in a random order from a coin flip where heads is moderate exercise and tails is the 90% intervals. The moderate intensity session will consist of 45 minutes of exercise at 45-55% of HRR. The 90% session will consist of 15 minutes of moderate intensity at 45-55% of HRR followed by six one minute bursts of exercise at 90% of HRR every two minutes followed by a 10 minute cooldown.

Data will be analyzed using a general linear model and logistic regression.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent time spent </= 3.9 mmol/L as measured by continuous glucose monitor
timeFrame: 12 hours post exercise (6:00 PM to 6:00 AM)
Secondary outcomes:
measure: Mean absolute glucose change (MAG-mmol/L/h) as measured by continuous glucose monitor
timeFrame: 12 hours post exercise (6:00 PM to 6:00 AM)
measure: Continuous overall net glycemic action (CONGA-mmol/L) as measured by continuous glucose monitor
timeFrame: 12 hours post exercise (6:00 PM to 6:00 AM)
Other outcomes:
measure: Cortisol
timeFrame: two hours post exercise
measure: Growth hormone
timeFrame: two hours post exercise
measure: Muscle mass as assessed by DEXA
timeFrame: Baseline appointment ~20 minutes
Locations:
city: Winnipeg
country: Canada
facility: Children's Hospital Research Institute of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba; Children's Hospital Research Institute of Manitoba
name: Jonathan McGavock, PhD
role: PRINCIPAL_INVESTIGATOR
References: