Type 1 DiabetesNCT05203640
Effects of Resistance Exercise on Blood Glucose in Post-menopausal Women With Type 1 Diabetes
A study testing High repetition (HI) and Moderate repetition (MOD) in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.
Trial summary
Regular physical activity has substantial health benefits in people with type 1 diabetes. The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- High repetition (HI) and Moderate repetition (MOD)
- 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 Apr 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- type 1 diabetes diagnosed for at least 1 year
- at least 12 months since last menstrual period
- physically able and willing to perform resistance exercise
- HbA1c < 10%
- residing near Edmonton, Alberta / able to attend laboratory based sessions at the University of Alberta
Who cannot join
- Individuals with 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.
- Individuals who are treated with medications (other than insulin) that affect glucose metabolism (e.g. atypical antipsychotics, corticosteroids)
- A body mass index >30kg/m2,
- Smoking
- Moderate to high alcohol intake (>2 drinks per day)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2R3
Jane E Yardley, PhD, 7806791688, jane.yardley@ualberta.ca
About this study
Official title: Acute Glycemic Effects of Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Regular physical activity has substantial health benefits in people with type 1 diabetes. The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. A major obstacle to providing specific physical activity and exercise advice is that there are still significant gaps in the fundamental understanding of the impact of physical activity and exercise on blood glucose levels in type 1 diabetes.
Women with type 1 diabetes have a substantial increase in cardiovascular risk once they have passed menopause. They may lose both bone quality and muscle mass at a faster rate with aging than those without diabetes. Overall, these changes greatly increase the risk of both cardiovascular and frailty related complications. Despite the many potential benefits of resistance exercise for post-menopausal women with type 1 diabetes, there are currently no published studies examining the effects of resistance exercise in this population. Before being able to design a clinical trial of resistance exercise, an examination of the acute effects of resistance exercise on blood glucose levels in post-menopausal women with type 1 diabetes is required.
The present study will compare the glycemic effects of a low resistance, high repetition (3 sets of 15 to 20 repetitions) weight lifting program to the effects of a moderate resistance, moderate repetition (3 sets of 8 to 10 repetitions). The investigators hypothesize that the high repetition program will be associated with a bigger decline in blood glucose during exercise, but that the moderate resistance program will be associated with a higher risk of post-exercise hypoglycemia.
Read the detailed description
Regular physical activity (PA) has substantial health benefits in people with type 1 diabetes (T1D). The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. A major obstacle to providing specific PA advice is that there are still significant gaps in the fundamental understanding of the impact of PA and exercise on blood glucose levels in type 1 diabetes. For example, many of the existing studies were performed either uniquely with male participants, or with very few female participants. In addition to knowing little about the blood glucose response to PA and exercise in females with type 1 diabetes in general, less is known about how menopause and the hormonal changes and impacts of age affect these outcomes.
Women with T1D have a substantial increase in cardiovascular risk once they have passed menopause. In addition to this increased risk for cardiovascular disease (CVD), individuals with T1D may lose both bone quality and muscle mass at a faster rate with aging than those without diabetes. Overall, these changes greatly increase the risk of both cardiovascular and frailty related complications in females with T1D. Despite the many potential benefits of resistance exercise for post-menopausal females with T1D, there are currently no published studies examining the effects of resistance exercise in this population. There are, in fact, no published exercise interventions of any type of exercise in post-menopausal females with T1D. As such, current guidelines for insulin adjustment and carbohydrate intake around PA and exercise may be inappropriate for post-menopausal women with T1D.
Pre-test measures: 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 menopause, PA levels, and medication. Blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. A blood sample will be drawn for assessment of HbA1c. 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. Indirect calorimetry will be used to assess oxygen consumption and carbon dioxide production and will be used to extrapolate the participant's aerobic capacity. Participants will then undergo a strength test for each of the seven exercises involved in the study, in order to estimate the their one repetition maximum (1RM - the maximum weight that can be lifted safely and with good form).
Testing sessions: Participants will be asked to arrive at the lab at around 4:00 pm 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 7 resistance exercises (leg press, chest press, leg curls, lat pulldowns, seated row, shoulder press, and abdominal crunches). One trial will consist of 3 sets of 15 to 20 repetitions at 50-60% of the participants pre-determined 1RM, and the other will be 3 sets of 8 to 10 repetitions at 75-80% 1RM. Blood samples will be drawn at baseline, at the end of exercise, and an hour post-exercise via an IV catheter. 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. Participants will be provided with log sheets to assist in this task 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 3 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. Background physical activity will be tracked using accelerometers.
Focus group/Interviews: After the exercise sessions have been completed, study participants will be invited to participate in a focus-group asking questions about their exercise experience, preferences between protocols, barriers to exercise, and other information they feel may improve their exercise experience. These focus groups will be conducted by a trained facilitator, and should take no more than two hours. For those who cannot attend the focus group, a video-conference to answer the questions in an interview format may be scheduled if they still wish to participate in this portion of the study.
- Conditions
- Type 1 Diabetes
- Being tested
- High repetition (HI), Moderate repetition (MOD)
- Keywords
- resistance 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.
High repetition (HI)Behavioural
Participants will perform 15 to 20 repetitions of 7 different exercises at 50% of their one repetition maximum
Moderate repetition (MOD)Behavioural
Participants will perform 8 to 10 repetitions of 7 different exercise at 75-80% of their one repetition maximum
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will be in a single arm that undergoes two separate interventions. These interventions will include a high repetition, low resistance protocol, and a moderate repetition, moderate intensity protocol. Receives: Behavioral: High repetition (HI); Behavioral: Moderate repetition (MOD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Change in blood glucose during and after exercise
Measured: from 0 minutes to 45 minutes, and from 45 minutes to 105 minutes
Secondary outcomes (9)
Mean continuous glucose monitoring (CGM) glucose
Interstitial glucose as measured by CGM
Measured: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
coefficient of variation (CV)
CV of CGM glucose
Measured: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
standard deviation (SD)
SD of CGM glucose
Measured: 0 to 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 was equal to or less than 3.9 mmol/L
Measured: 0 to 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 was equal to or above 10.0 mmol/L
Measured: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in range
percentage of time spent between 4.0 and 9.9 mmol/L
Measured: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in hypoglycemia
percentage of time spent equal to or below 3.9 mmol/L
Measured: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in hyperglycemia
percentage of time spent at or above 10.0 mmol/L
Measured: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
carbohydrate supplementation
grams of carbohydrate provided to prevent hypoglycemia during exercise
Measured: 0 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 Apr 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203640
- Sponsor's protocol ID
- Pro00112972
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2022
- Last updated
- 8 Jul 2025
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Glycemic Effects of Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05203640
- Acronym / sponsor ID
- Pro00112972
- Conditions
- Type 1 Diabetes
- Keywords
- resistance exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- 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.
Regular physical activity has substantial health benefits in people with type 1 diabetes. The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. A major obstacle to providing specific physical activity and exercise advice is that there are still significant gaps in the fundamental understanding of the impact of physical activity and exercise on blood glucose levels in type 1 diabetes.
Women with type 1 diabetes have a substantial increase in cardiovascular risk once they have passed menopause. They may lose both bone quality and muscle mass at a faster rate with aging than those without diabetes. Overall, these changes greatly increase the risk of both cardiovascular and frailty related complications. Despite the many potential benefits of resistance exercise for post-menopausal women with type 1 diabetes, there are currently no published studies examining the effects of resistance exercise in this population. Before being able to design a clinical trial of resistance exercise, an examination of the acute effects of resistance exercise on blood glucose levels in post-menopausal women with type 1 diabetes is required.
The present study will compare the glycemic effects of a low resistance, high repetition (3 sets of 15 to 20 repetitions) weight lifting program to the effects of a moderate resistance, moderate repetition (3 sets of 8 to 10 repetitions). The investigators hypothesize that the high repetition program will be associated with a bigger decline in blood glucose during exercise, but that the moderate resistance program will be associated with a higher risk of post-exercise hypoglycemia.
Detailed description
Regular physical activity (PA) has substantial health benefits in people with type 1 diabetes (T1D). The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. A major obstacle to providing specific PA advice is that there are still significant gaps in the fundamental understanding of the impact of PA and exercise on blood glucose levels in type 1 diabetes. For example, many of the existing studies were performed either uniquely with male participants, or with very few female participants. In addition to knowing little about the blood glucose response to PA and exercise in females with type 1 diabetes in general, less is known about how menopause and the hormonal changes and impacts of age affect these outcomes.
Women with T1D have a substantial increase in cardiovascular risk once they have passed menopause. In addition to this increased risk for cardiovascular disease (CVD), individuals with T1D may lose both bone quality and muscle mass at a faster rate with aging than those without diabetes. Overall, these changes greatly increase the risk of both cardiovascular and frailty related complications in females with T1D. Despite the many potential benefits of resistance exercise for post-menopausal females with T1D, there are currently no published studies examining the effects of resistance exercise in this population. There are, in fact, no published exercise interventions of any type of exercise in post-menopausal females with T1D. As such, current guidelines for insulin adjustment and carbohydrate intake around PA and exercise may be inappropriate for post-menopausal women with T1D.
Pre-test measures: 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 menopause, PA levels, and medication. Blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. A blood sample will be drawn for assessment of HbA1c. 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. Indirect calorimetry will be used to assess oxygen consumption and carbon dioxide production and will be used to extrapolate the participant's aerobic capacity. Participants will then undergo a strength test for each of the seven exercises involved in the study, in order to estimate the their one repetition maximum (1RM - the maximum weight that can be lifted safely and with good form).
Testing sessions: Participants will be asked to arrive at the lab at around 4:00 pm 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 7 resistance exercises (leg press, chest press, leg curls, lat pulldowns, seated row, shoulder press, and abdominal crunches). One trial will consist of 3 sets of 15 to 20 repetitions at 50-60% of the participants pre-determined 1RM, and the other will be 3 sets of 8 to 10 repetitions at 75-80% 1RM. Blood samples will be drawn at baseline, at the end of exercise, and an hour post-exercise via an IV catheter. 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. Participants will be provided with log sheets to assist in this task 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 3 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. Background physical activity will be tracked using accelerometers.
Focus group/Interviews: After the exercise sessions have been completed, study participants will be invited to participate in a focus-group asking questions about their exercise experience, preferences between protocols, barriers to exercise, and other information they feel may improve their exercise experience. These focus groups will be conducted by a trained facilitator, and should take no more than two hours. For those who cannot attend the focus group, a video-conference to answer the questions in an interview format may be scheduled if they still wish to participate in this portion of 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: High repetition (HI), Behavioral: Moderate repetition (MOD)All participants will be in a single arm that undergoes two separate interventions. These interventions will include a high repetition, low resistance protocol, and a moderate repetition, moderate intensity protocol. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female
- type 1 diabetes diagnosed for at least 1 year
- at least 12 months since last menstrual period
- physically able and willing to perform resistance exercise
- HbA1c < 10%
Key exclusion criteria (11 listed)
- Individuals with 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 |
|---|---|---|
| High repetition (HI)Participants will perform 15 to 20 repetitions of 7 different exercises at 50% of their one repetition maximum | Behavioural | All participants |
| Moderate repetition (MOD)Participants will perform 8 to 10 repetitions of 7 different exercise at 75-80% of their one repetition maximum | Behavioural | All participants |
Primary outcome
Blood glucose
Time frame: from 0 minutes to 45 minutes, and from 45 minutes to 105 minutes
Change in blood glucose during and after exercise
9 secondary outcomes
Mean continuous glucose monitoring (CGM) glucose
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
coefficient of variation (CV)
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
standard deviation (SD)
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
frequency of hypoglycemia
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
frequency of hyperglycemia
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in range
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in hypoglycemia
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
percent time in hyperglycemia
Time frame: 0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise
carbohydrate supplementation
Time frame: 0 to 45 minutes (during exercise)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High repetition (HI) and Moderate repetition (MOD) 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 6 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Yardley, PhD (780-679-1688, jane.yardley@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: from 0 minutes to 45 minutes, and from 45 minutes to 105 minutes). 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 8 Jul 2025.