Type 1 DiabetesNCT05188027
Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
A study testing Aerobic Exercise, Resistance Exercise and No exercise in people with Type 1 Diabetes and Post-menopause, run by University of Alberta at 2 sites in Canada.
Trial summary
Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Type 1 Diabetes, Post-menopause
- What is being tested?
- Aerobic Exercise, Resistance Exercise and No exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Nov 2021to 30 Mar 2027
- 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
- type 1 diabetes, diagnosed for at least one year
- post-menopause (at least one year since last menstrual period), or have had a hysterectomy and bilateral salpingo oophorectomy
- able to perform aerobic and resistance exercise
- able to visit the lab in Edmonton, Alberta (University of Alberta)
Who cannot join
- HbA1c > 9.9 %
- frequent and unpredictable hypoglycemia
- change in insulin management strategy within the last 2 months
- blood pressure > 140 / 95
- severe peripheral neuropathy
- history of cardiovascular disease
Show all 11Show fewer
- musculoskeletal injuries interfering with exercise performance
- use of medications (other than insulin) that affect glucose metabolism
- BMI > 30 kg/m2
- smoking
- moderate to high alcohol intake (> 2 drinks/day)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2R3
Jane E Yardley, PhD, 7806791688, jane.yardley@ualberta.ca
- Recruiting
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Jane Yardley, PhD, jane.yardley@ircm.qc.ca
About this study
Official title: Acute Glycemic Effects of Aerobic and Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). One will be a moderate aerobic exercise session (30 minutes of exercise, 60 minutes of recovery), and the third will be a moderate weight-lifting session (~30 minutes of exercise, 60 minutes of recovery).The investigators will measure changes in blood glucose during exercise by drawing blood during and after exercise. Post-exercise glucose trends will be examined using continuous glucose monitoring.
Read the detailed description
Pre-test measures: Interested participants will be invited to either the Exercise Physiology laboratory the Augustana campus of the University of Alberta, or the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They 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 maximal aerobic capacity test with ECG monitoring, under the supervision of a certified exercise physiologist. 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 undergo a strength test for each of the ten exercises involved in the study, in order to estimate the their 1 repetition maximum. Participants will also be asked to undergo a dual energy x-ray absorptiometry (DXA) scan for body composition in the Clinical Research Unit at the Alberta Diabetes Institute. While this procedure generally requires proof of a negative pregnancy test, participants will be provided with a waiver in order to decline this test (in light of their menopausal status).
Testing sessions: Participants will be asked to arrive at the lab at around 4:00 pm for all three sessions, which will be randomly assigned. During the sessions, participants will be asked to perform one of the three activities: 1) seated rest 2) aerobic exercise (walking on a treadmill at 50% of the participant's pre-determined VO2max) or 3) resistance exercise consisting of 1 set of 10 repetitions of 10 different exercises with 90 seconds rest between sets. Blood samples will be drawn at baseline, after 10, 20 and 30 minutes of exercise, along with 30- and 60-minutes post-exercise via an IV catheter. Indirect calorimetry will be used to ensure that the participant is exercising at the appropriate intensity. 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. The investigators will provide them with log sheets to assist in this task. They 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, or on the back of the arm of the participant, approximately 2 days prior to the first testing session. The Dexcom G6 CGM receiver 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 return the receiver to enable the upload of their data to Dexcom Clarity by the study team.
Interviews: During the third and final testing session, study participants will be invited to answer questions about their study participation experience, exercise preferences, barriers to exercise, and other information they feel may improve their exercise experience. These interviews will be audio recorded and transcribed.
- Conditions
- Type 1 Diabetes, Post-menopause
- Being tested
- Aerobic Exercise, Resistance Exercise, No exercise
- Keywords
- Exercise, Physical activity
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Walking at 60% of maximal aerobic capacity on a treadmill
Resistance ExerciseOther
Performing one set of 10 repetitions of 10 different weight-lifting exercises
No exerciseOther
Participants will rest in a supine position for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will take part in all three testing conditions Receives: Other: Aerobic Exercise; Other: Resistance Exercise; Other: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Change in blood glucose
Measured: From 0 minutes to 45 minutes (beginning to the end of exercise/control) and then for 60 minutes after exercise
Secondary outcomes (9)
mean continuous glucose monitoring (CGM) glucose
mean of all measurements over the selected time frames
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
coefficient of variation (CV) of CGM glucose
CV of CGM glucose over the selected time frames
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
standard deviation (SD)
SD of CGM glucose over the selected time frames
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
frequency of hypoglycemia
number of times that CGM glucose is equal to or less than 3.9 mmol/L
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) 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, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
percent time spent in hyperglycemia
percentage of time spent with CGM glucose equal to or greater than 10.0 mmol/L
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
percent time spent in hypoglycemia
percentage of time spent with CGM glucose equal to or lower than 3.9 mmol/L
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
percent time spent in range
percent of time spent with CGM glucose between 4.0 and 9.9 mmol/L
Measured: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
carbohydrate supplementation
grams of carbohydrate provided during exercise to prevent hypoglycemia
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 posted12 Jan 2022
- Study start16 Nov 2021
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188027
- Sponsor's protocol ID
- Pro00107673
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2021
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Glycemic Effects of Aerobic and Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05188027
- Acronym / sponsor ID
- Pro00107673
- Conditions
- Type 1 Diabetes, Post-menopause
- Keywords
- Exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 12 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.
Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). One will be a moderate aerobic exercise session (30 minutes of exercise, 60 minutes of recovery), and the third will be a moderate weight-lifting session (~30 minutes of exercise, 60 minutes of recovery).The investigators will measure changes in blood glucose during exercise by drawing blood during and after exercise. Post-exercise glucose trends will be examined using continuous glucose monitoring.
Detailed description
Pre-test measures: Interested participants will be invited to either the Exercise Physiology laboratory the Augustana campus of the University of Alberta, or the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They 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 maximal aerobic capacity test with ECG monitoring, under the supervision of a certified exercise physiologist. 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 undergo a strength test for each of the ten exercises involved in the study, in order to estimate the their 1 repetition maximum. Participants will also be asked to undergo a dual energy x-ray absorptiometry (DXA) scan for body composition in the Clinical Research Unit at the Alberta Diabetes Institute. While this procedure generally requires proof of a negative pregnancy test, participants will be provided with a waiver in order to decline this test (in light of their menopausal status).
Testing sessions: Participants will be asked to arrive at the lab at around 4:00 pm for all three sessions, which will be randomly assigned. During the sessions, participants will be asked to perform one of the three activities: 1) seated rest 2) aerobic exercise (walking on a treadmill at 50% of the participant's pre-determined VO2max) or 3) resistance exercise consisting of 1 set of 10 repetitions of 10 different exercises with 90 seconds rest between sets. Blood samples will be drawn at baseline, after 10, 20 and 30 minutes of exercise, along with 30- and 60-minutes post-exercise via an IV catheter. Indirect calorimetry will be used to ensure that the participant is exercising at the appropriate intensity. 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. The investigators will provide them with log sheets to assist in this task. They 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, or on the back of the arm of the participant, approximately 2 days prior to the first testing session. The Dexcom G6 CGM receiver 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 return the receiver to enable the upload of their data to Dexcom Clarity by the study team.
Interviews: During the third and final testing session, study participants will be invited to answer questions about their study participation experience, exercise preferences, barriers to exercise, and other information they feel may improve their exercise experience. These interviews will be audio recorded and transcribed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Aerobic Exercise, Other: Resistance Exercise, Other: No exerciseAll participants will take part in all three testing conditions |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 1 diabetes, diagnosed for at least one year
- post-menopause (at least one year since last menstrual period), or have had a hysterectomy and bilateral salpingo oophorectomy
- able to perform aerobic and resistance exercise
- able to visit the lab in Edmonton, Alberta (University of Alberta)
Key exclusion criteria (11 listed)
- HbA1c > 9.9 %
- frequent and unpredictable hypoglycemia
- change in insulin management strategy within the last 2 months
- blood pressure > 140 / 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 |
|---|---|---|
| Aerobic ExerciseWalking at 60% of maximal aerobic capacity on a treadmill | Other | All participants |
| Resistance ExercisePerforming one set of 10 repetitions of 10 different weight-lifting exercises | Other | All participants |
| No exerciseParticipants will rest in a supine position for 30 minutes. | Other | All participants |
Primary outcome
Blood glucose
Time frame: From 0 minutes to 45 minutes (beginning to the end of exercise/control) and then for 60 minutes after exercise
Change in blood glucose
9 secondary outcomes
mean continuous glucose monitoring (CGM) glucose
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
coefficient of variation (CV) of CGM glucose
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
standard deviation (SD)
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
frequency of hypoglycemia
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
frequency of hyperglycemia
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
percent time spent in hyperglycemia
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
percent time spent in hypoglycemia
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
percent time spent in range
Time frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
carbohydrate supplementation
Time frame: from 0 minutes 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 16 Mar 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Resistance Exercise and No exercise in people with Type 1 Diabetes and Post-menopause, run by University of Alberta at 2 sites 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 4 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 E 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 (beginning to the end of exercise/control) and then for 60 minutes after 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 16 Mar 2026.