Type 1 DiabetesNCT05203653
Effectiveness of Aerobic Exercise to Mitigate Hyperglycemia After Fasted Resistance Exercise
A study testing Resistance exercise only and Resistance exercise plus cool down in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.
Trial summary
Certain types and timings of exercise are known to cause hyperglycemia (high blood glucose) in people with type 1 diabetes. Hyperglycemia increases the risk of most long-term complications for individuals with this complication. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Resistance exercise only and Resistance exercise plus cool down
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 19 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with type 1 diabetes for more than 12 months
- using either multiple daily insulin injections or continuous subcutaneous insulin infusion
- willing and able to perform resistance exercise
- HbA1c < 10.0%
- ability to attend laboratory-based sessions at the University of Alberta in Edmonton
Who cannot join
- HbA1c >9.9%
- Frequent and unpredictable hypoglycaemia
- A change in insulin management strategy within two months of the study
- blood pressure > 144/95
- severe peripheral neuropathy
- a history of cardiovascular disease
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- musculoskeletal injuries affecting the ability to perform resistance exercise.
- treatment with medications (other than insulin) that affect glucose metabolism (e.g. atypical antipsychotics, corticosteroids)
- body mass index >30kg/m2
- smoking
- moderate to high alcohol intake (>2 drinks per day)
Trial locations and contacts
1 site in 1 country.
About this study
Certain types and timings of exercise are known to cause hyperglycemia (high blood glucose) in people with type 1 diabetes. Hyperglycemia increases the risk of most long-term complications for individuals with this complication. However, using insulin corrections to treat post-exercise hyperglycemia can increase the risk of late-onset hypoglycemia (low-blood glucose).
Anaerobic activities performed in a fasted state are known to cause increases in blood glucose and post-exercise hyperglycemia in most individuals with type 1 diabetes. This study proposes to examine the effect of a ten-minute aerobic cool down after resistance exercise on the blood glucose response to fasted exercise of individuals with type 1 diabetes. It is hypothesized that adding a short aerobic cool down at the end of a fasted resistance exercise session will attenuate post-exercise increases in blood glucose observed in previous studies, leading to less post-exercise hyperglycemia.
Read the detailed description
Individuals with type 1 diabetes (T1D), are at elevated risk of low muscular strength, as well as accelerated decline in muscle strength and functional status with aging. Resistance exercise (RE) is a proven intervention that has been demonstrated to improve physical function, muscle mass, body composition, mental health, bone mineral density, insulin sensitivity, blood pressure, lipid profiles, and cardiovascular health for all adults. Clinical guidelines recommend that individuals with T1D perform RE twice weekly to optimally benefit from RE yet most individuals with T1D are unable to meet these recommendations. Two barriers to exercise responsible for this discrepancy are a fear of hypoglycemia from exercise, and a loss of control over diabetes. To limit barriers to exercise, much research has been done to identify exercise modalities that have minimal risk for hypoglycemia, including recent investigations demonstrating a blood glucose increase leading to hyperglycemia in response to RE while participants are fasted. Hyperglycemia frequency is directly related to the incidence of diabetes-related complications, so exercise recommendations should minimize risk of hyperglycemic and hypoglycemic responses. Clinical guidelines for post-exercise hyperglycemia recommend a corrective insulin dose or a brief aerobic cool down, however the efficacy of an aerobic cool down has yet to be empirically tested. Additionally, overcorrection of hyperglycaemia with insulin after exercise can result in an increased risk of severe late onset hypoglycaemia, which could even be fatal.
The study will have a randomized, repeated measures design with two testing sessions (one with a cool down and one without a cool down) in addition to a baseline fitness assessment. Interested participants will be invited to the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. Participants will be asked questions related to diabetes care, physical activity levels, and medication. Blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. Those who meet all eligibility criteria and complete informed consent forms will be asked to complete the initial exercise tests. Participants will perform a submaximal aerobic capacity test to extrapolate the participant's aerobic capacity. Participants will also undergo a strength test for each of the seven exercises involved in the study, in order to estimate the maximum weight they can move for 3 sets of 8 repetitions (8RM). During this session the investigators will introduce participants to the activity monitor (accelerometer) that will be worn on the day before, the day of, and the day after each testing session. The accelerometer will provide information on background physical activity and sleep patterns that might act as confounders where the blood glucose responses to exercise are concerned.
Testing sessions: Participants will be asked to arrive at the lab between 7:00 and 8:00 am for both sessions, which will be randomly assigned by tossing a fair coin. During the sessions, participants will be asked to perform a total of seven resistance exercises (leg press, chest press, leg curls, lat pulldowns, seated row, shoulder press, and abdominal crunches). The protocol will be 3 sets of 8 repetitions at the participant's 8 RM. Participants will be asked to match their daily food and insulin intake as closely as possible from one testing session to the next for the day before, day of and day after the testing session. During this time participants will also wear an accelerometer on their waist during the day, and on their non-dominant wrist at night. Participants will be provided with log sheets to assist in both of these tasks and will also be asked to avoid strenuous exercise and alcohol intake.
A CGM sensor will be subcutaneously inserted by one of the investigators (trained by a group from the CGM manufacturer) into the anterior abdominal area of the participant approximately 2 days prior to the first testing session. The Dexcom G6 CGM will store glucose data every 5 minutes for up to 10 days. The participant will be instructed on how to remove their sensor at least 24 hours after the exercise session, and will be asked to upload their data to Dexcom Clarity to share with the study team. If the participant habitually uses their Dexcom G6 in their diabetes care, they will be provided with the option to start their own CGM for the study.
- Conditions
- Type 1 Diabetes
- Being tested
- Resistance exercise only, Resistance exercise plus cool down
- Keywords
- resistance exercise, aerobic exercise
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise onlyBehavioural
Participants will perform 3 sets of 8 repetitions of 7 different exercises while in a fasted state.
Resistance exercise plus cool downBehavioural
Participants will perform 3 sets of 8 repetitions of 7 different exercises while in a fasted state followed by a 10-minute light aerobic cool down
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will undergo two separate testing sessions Receives: Behavioral: Resistance exercise only; Behavioral: Resistance exercise plus cool down |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent time spent in hyperglycemia
amount of time spent with interstitial glucose (measured by continuous glucose monitoring) greater than 9.9 mmol/L
Measured: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
Secondary outcomes (6)
mean continuous glucose monitoring (CGM) glucose
mean values of interstitial glucose levels measured by CGM
Measured: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
frequency of hyperglycemia
number of times that CGM glucose is equal to or greater than 10.0 mmol/L
Measured: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
frequency of hypoglycemia
number of times that CGM glucose is equal to or lower than 3.9 mmol/L
Measured: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time spent in hypoglycemia
percentage of time that CGM glucose is equal to or less than 3.9 mmol/L
Measured: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in range
percentage of time that CGM glucose is between 4.0 and 9.9 mmol/L
Measured: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
capillary glucose
change in capillary glucose during exercise
Measured: from 0 minutes to 45 minutes (during exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Mar 2022
- Primary completion19 Mar 2023
- Study completion19 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203653
- Sponsor's protocol ID
- Pro00115197
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aerobic Exercise to Mitigate Hyperglycemia After Fasted Resistance Exercise
- ClinicalTrials.gov ID
- NCT05203653
- Acronym / sponsor ID
- Pro00115197
- Conditions
- Type 1 Diabetes
- Keywords
- resistance exercise, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 19 Mar 2023 (actual)
- Study completion
- 19 Mar 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Certain types and timings of exercise are known to cause hyperglycemia (high blood glucose) in people with type 1 diabetes. Hyperglycemia increases the risk of most long-term complications for individuals with this complication. However, using insulin corrections to treat post-exercise hyperglycemia can increase the risk of late-onset hypoglycemia (low-blood glucose).
Anaerobic activities performed in a fasted state are known to cause increases in blood glucose and post-exercise hyperglycemia in most individuals with type 1 diabetes. This study proposes to examine the effect of a ten-minute aerobic cool down after resistance exercise on the blood glucose response to fasted exercise of individuals with type 1 diabetes. It is hypothesized that adding a short aerobic cool down at the end of a fasted resistance exercise session will attenuate post-exercise increases in blood glucose observed in previous studies, leading to less post-exercise hyperglycemia.
Detailed description
Individuals with type 1 diabetes (T1D), are at elevated risk of low muscular strength, as well as accelerated decline in muscle strength and functional status with aging. Resistance exercise (RE) is a proven intervention that has been demonstrated to improve physical function, muscle mass, body composition, mental health, bone mineral density, insulin sensitivity, blood pressure, lipid profiles, and cardiovascular health for all adults. Clinical guidelines recommend that individuals with T1D perform RE twice weekly to optimally benefit from RE yet most individuals with T1D are unable to meet these recommendations. Two barriers to exercise responsible for this discrepancy are a fear of hypoglycemia from exercise, and a loss of control over diabetes. To limit barriers to exercise, much research has been done to identify exercise modalities that have minimal risk for hypoglycemia, including recent investigations demonstrating a blood glucose increase leading to hyperglycemia in response to RE while participants are fasted. Hyperglycemia frequency is directly related to the incidence of diabetes-related complications, so exercise recommendations should minimize risk of hyperglycemic and hypoglycemic responses. Clinical guidelines for post-exercise hyperglycemia recommend a corrective insulin dose or a brief aerobic cool down, however the efficacy of an aerobic cool down has yet to be empirically tested. Additionally, overcorrection of hyperglycaemia with insulin after exercise can result in an increased risk of severe late onset hypoglycaemia, which could even be fatal.
The study will have a randomized, repeated measures design with two testing sessions (one with a cool down and one without a cool down) in addition to a baseline fitness assessment. Interested participants will be invited to the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. Participants will be asked questions related to diabetes care, physical activity levels, and medication. Blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. Those who meet all eligibility criteria and complete informed consent forms will be asked to complete the initial exercise tests. Participants will perform a submaximal aerobic capacity test to extrapolate the participant's aerobic capacity. Participants will also undergo a strength test for each of the seven exercises involved in the study, in order to estimate the maximum weight they can move for 3 sets of 8 repetitions (8RM). During this session the investigators will introduce participants to the activity monitor (accelerometer) that will be worn on the day before, the day of, and the day after each testing session. The accelerometer will provide information on background physical activity and sleep patterns that might act as confounders where the blood glucose responses to exercise are concerned.
Testing sessions: Participants will be asked to arrive at the lab between 7:00 and 8:00 am for both sessions, which will be randomly assigned by tossing a fair coin. During the sessions, participants will be asked to perform a total of seven resistance exercises (leg press, chest press, leg curls, lat pulldowns, seated row, shoulder press, and abdominal crunches). The protocol will be 3 sets of 8 repetitions at the participant's 8 RM. Participants will be asked to match their daily food and insulin intake as closely as possible from one testing session to the next for the day before, day of and day after the testing session. During this time participants will also wear an accelerometer on their waist during the day, and on their non-dominant wrist at night. Participants will be provided with log sheets to assist in both of these tasks and will also be asked to avoid strenuous exercise and alcohol intake.
A CGM sensor will be subcutaneously inserted by one of the investigators (trained by a group from the CGM manufacturer) into the anterior abdominal area of the participant approximately 2 days prior to the first testing session. The Dexcom G6 CGM will store glucose data every 5 minutes for up to 10 days. The participant will be instructed on how to remove their sensor at least 24 hours after the exercise session, and will be asked to upload their data to Dexcom Clarity to share with the study team. If the participant habitually uses their Dexcom G6 in their diabetes care, they will be provided with the option to start their own CGM for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Behavioral: Resistance exercise only, Behavioral: Resistance exercise plus cool downAll participants will undergo two separate testing sessions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosed with type 1 diabetes for more than 12 months
- using either multiple daily insulin injections or continuous subcutaneous insulin infusion
- willing and able to perform resistance exercise
- HbA1c < 10.0%
- ability to attend laboratory-based sessions at the University of Alberta in Edmonton
Key exclusion criteria (11 listed)
- HbA1c >9.9%
- Frequent and unpredictable hypoglycaemia
- A change in insulin management strategy within two months of the study
- blood pressure > 144/95
- severe peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise onlyParticipants will perform 3 sets of 8 repetitions of 7 different exercises while in a fasted state. | Behavioural | All participants |
| Resistance exercise plus cool downParticipants will perform 3 sets of 8 repetitions of 7 different exercises while in a fasted state followed by a 10-minute light aerobic cool down | Behavioural | All participants |
Primary outcome
percent time spent in hyperglycemia
Time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
amount of time spent with interstitial glucose (measured by continuous glucose monitoring) greater than 9.9 mmol/L
6 secondary outcomes
mean continuous glucose monitoring (CGM) glucose
Time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
frequency of hyperglycemia
Time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
frequency of hypoglycemia
Time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time spent in hypoglycemia
Time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in range
Time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
capillary glucose
Time frame: from 0 minutes to 45 minutes (during exercise)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise only and Resistance exercise plus cool down in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent time spent in hyperglycemia (time frame: 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.