Type 1 Diabetes (T1D)FLEX-T1DNCT07851662
Functional Mobility and Resistance Exercise for Postmenopausal Females With Type 1 Diabetes
A study testing Resistance exercise in people with Type 1 Diabetes (T1D) and Menopause, run by Institut de Recherches Cliniques de Montreal at 3 sites in Canada.
Trial summary
Improvements in diabetes care and technology have led to people with type 1 diabetes living longer. There are now more seniors than ever living with this complex health condition. With aging, type 1 diabetes affects both bone (more brittle), and muscle (loss of size and strength). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Type 1 Diabetes (T1D), Menopause
- What is being tested?
- Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2026to Dec 2030
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) female
- 2) clinical diagnosis of T1D requiring continuous insulin therapy [(either by multiple daily injections or continuous subcutaneous insulin infusion (insulin pumps)] for > 1 yr
- 3) aged ≥60 yrs, or ≥50 yrs with signs or symptoms of clinical frailty (level 4 on the Clinical Frailty Scale)
- 4) physically inactive (<30 mins of aerobic activity <3x/week; no resistance exercise)
- 5) postmenopausal (no menstrual periods in the previous 12 months, or who have had a hysterectomy and bilateral salpingo-oophorectomy with ≥1 yr having elapsed since surgery)
Who cannot join
- 1) unable to communicate in English/French
- 2) unwilling/unable to sign informed consent
- 3) having performed RT in the past 6 months
- 4) recent (last 3 months) or multiple episodes (>2 in last 12 months) of severe hypoglycemia and/or diabetic ketoacidosis
- 5) those with PA restrictions due to:
- a) intermittent claudication
Show all 13Show fewer
- b) severe peripheral neuropathy
- c) active proliferative retinopathy
- d) unstable cardiac or pulmonary disease
- e) disabling stroke
- f) significant renal disease (estimated GFR<25 mL/min/1.73 m2 or urine albumin/creatinine ratio >150 mg/mmol)
- g) uncontrolled hypertension (BP>150 mmHg systolic or >95 mmHg diastolic while seated)
- h) musculoskeletal injury, foot wound or amputation that would affect the ability to exercise
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Corinne Suppere, MSc contact
Canada3 sites
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2E1
Normand G Boulé, PhD, 1-780-492-4695, nboule@ualberta.ca
McMaster University
Hamilton, Ontario
Irena Rebalka, PhD, 1-905-525-9140 ext. 22273, rebalka@mcmaster.ca
Institut de recherches cliniques de Montreal
Montreal, Quebec, H2W 1R7
Corinne Suppere, MSc, 514-987-5597, csuppere@ircm.qc.ca
Kia Salimi, PhD
About this study
Official title: A Randomized Controlled Trial of Functional MobiLity and Resistance EXercise for Postmenopausal Females With Type 1 Diabetes: the FLEX-T1D Trial
Improvements in diabetes care and technology have led to people with type 1 diabetes living longer. There are now more seniors than ever living with this complex health condition. With aging, type 1 diabetes affects both bone (more brittle), and muscle (loss of size and strength). This loss happens faster and to a greater extent in females than in males, and greatly increases the risk of frailty and falls. It may also occur more quickly in individuals who have higher blood glucose (sugar) levels.
Frailty is an important factor to address. In older females, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization, and even death. Performing regular exercise helps to maintain the strength and quality of both muscles and bones with aging. The best type of exercise to help maintain the ability to perform activities of daily living (known as functional mobility) for this population is currently unknown. Resistance exercise (weightlifting) helps to prevent decreases in mobility in seniors without diabetes. However, in the context of type 1 diabetes, high blood sugar levels could negatively impact these potential strength benefits and low blood glucose could lead to falls. As such, any exercise program that causes swings in glucose levels may hinder rather than help.
The goal of this study is to evaluate the effect of weightlifting over a 6-month timeframe on functional mobility in postmenopausal females with type 1 diabetes, compared to a group that does not train. the investigators will also assess its effects on blood sugar variability and the risk of hypoglycemia. Like different medications, not all exercise is equal. Creating more knowledge about the benefits of specific types of exercise in this population will allow us to be more precise in our exercise recommendations for living longer and more independently with type 1 diabetes.
Read the detailed description
Background: Type 1 diabetes, an autoimmune condition resulting in the near-absence of insulin secretion, requires lifelong exogenous insulin to manage blood glucose levels. Due to fear of hypoglycemia, which can be fatal, many people with type 1 diabetes maintain blood glucose levels slightly higher than the physiological range. This hyperglycemia is associated with many diabetes-related complications, including nephropathy, retinopathy, neuropathy and cardiovascular disease. It is also associated with an accelerated decrease in bone quality and muscle strength/quality with aging, creating a higher risk of age-related musculoskeletal fragility. The effects are more prominent in females than they are in males, particularly after menopause. As a result, postmenopausal females with type 1 diabetes have an especially high risk of frailty.
Frailty among older adults with type 1 diabetes is an important problem to address. With improvements in diabetes care/technology, people with type 1 diabetes are living longer, leading to a higher prevalence of type 1 diabetes among seniors. In older females without diabetes, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization and even death. These risks may be accentuated for postmenopausal females living with type 1 diabetes. Regular exercise helps to maintain the strength and quality of muscles and bones with aging. The best type of exercise to help maintain functional mobility in postmenopausal females with type 1 diabetes while not sacrificing tight glycemic management is currently unknown. Resistance exercise (weight lifting) helps prevent decreases in mobility in seniors without diabetes. In people with type 1 diabetes it is often associated with smaller blood glucose declines than aerobic exercise during activity, but has also been reported to increase blood glucose levels in some situations.
It may also increase hypoglycemia occurrence in the hours after exercise. Hyperglycemia could negatively affect potential strength benefits. Frequent hypoglycemia increases the risk of falls and injury. Unfortunately, most of the available data were collected on young, fit males, limiting our ability to create evidence-based exercise guidelines for healthful and independent aging for postemenopausal females with type 1 diabetes. As there are known sex-related differences in physiological exercise responses and gender-related differences in activity preferences, studying females and males separately is warranted.
Goal: The goal of the study is to create knowledge around resistance exercise effects on functional mobility in postmenopausal females with type 1 diabetes. The investigators will also assess their impact on 24-hour glycemia (continuous glucose monitoring), bone mineral density (DXA) and self-reported quality of life. Finally, the investigators will compare these outcomes to a group who did not exercise during the same time frame.
Methods/Approaches: To achieve this goal, the investigators will conduct a 6-month randomized controlled trial across three sites to assess the impact of supervised resistance exercise on functional mobility (timed up and go test) compared to no exercise in postmenopausal females with type 1 diabetes. The investigators will recruit postmenopausal females with type 1 diabetes who are not currently meeting physical activity guidelines. All participants will undergo a 4-week run-in period for exercise familiarization and diabetes care optimization, followed by 22 weeks of the assigned treatment. Measures will be taken before run-in and at the end of the intervention by personnel blinded to group assignment.
Expected Outcomes: This project will fill an important void in the information being used to produce evidence-based guildeines for people with type 1 diabetes by providing more precise advice for postmenopausal females with type 1 diabetes.
- Conditions
- Type 1 Diabetes (T1D), Menopause
- Being tested
- Resistance exercise
- Keywords
- randomized controlled trial, resistance exercise, supervised training
- 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 exerciseBehavioural
Supervised progressive resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise | Experimental | Supervised progressive resistance exercise training three times weekly Receives: Behavioral: Resistance exercise |
| wait-list control | No intervention | Usual care. Participants will be offered the training program at the end of the 6-month control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the time (in seconds) taken to complete the timed up and go test test
The test begins with the participant sitting correctly in a chair with arms fixed (so as not to move when the participant stands), with her back resting on the back of the chair. When the timer says "Go" the participant will stand, walk to a line 3 metres away from the chair, turn around, walk back and sit down. The timing starts with "Go" and ends when the participant is seated.
Measured: Baseline and 6 months (post-training)
Secondary outcomes (4)
change in 30-second chair stand test
The number of full stands that can be completed in 30 sec with hands folded across the chest
Measured: Baseline and 6 months (post-training)
Change in 6-minute walk test
The number of meters walked around a set course in 6 minutes will be measured
Measured: Baseline and 6 months (post-training)
Change in isometric grip strength
Participants will stand with their arm at their side; elbow bent at 90 degrees. Applying the force in a smooth motion, they will squeeze a dynamometer as hard as possible for 5 secs. This test will be performed three times for each hand, with the average of the three measurements being recorded
Measured: Baseline and 6 months (post-training)
Eight repetition maximum (8RM) strength test
The participants will perform repetitions of the exercise as weight is gradually increased until the weight at which they can only perform 8 repetitions with good form. Exercises will include leg press and chest press.
Measured: Baseline and 6 months (post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of Alberta
- Responsible party
- Principal investigator, Jane Yardley, Institut de Recherches Cliniques de Montreal
- Investigators
- Jane E Yardley, PhD, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851662
- Sponsor's protocol ID
- 2027-1393
- Acronym
- FLEX-T1D
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Functional MobiLity and Resistance EXercise for Postmenopausal Females With Type 1 Diabetes: the FLEX-T1D Trial
- ClinicalTrials.gov ID
- NCT07851662
- Acronym / sponsor ID
- FLEX-T1D / 2027-1393
- Conditions
- Type 1 Diabetes (T1D), Menopause
- Keywords
- randomized controlled trial, resistance exercise, supervised training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- McMaster University, University of Alberta
- Study start
- Dec 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Oct 2026 (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.
Improvements in diabetes care and technology have led to people with type 1 diabetes living longer. There are now more seniors than ever living with this complex health condition. With aging, type 1 diabetes affects both bone (more brittle), and muscle (loss of size and strength). This loss happens faster and to a greater extent in females than in males, and greatly increases the risk of frailty and falls. It may also occur more quickly in individuals who have higher blood glucose (sugar) levels.
Frailty is an important factor to address. In older females, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization, and even death. Performing regular exercise helps to maintain the strength and quality of both muscles and bones with aging. The best type of exercise to help maintain the ability to perform activities of daily living (known as functional mobility) for this population is currently unknown. Resistance exercise (weightlifting) helps to prevent decreases in mobility in seniors without diabetes. However, in the context of type 1 diabetes, high blood sugar levels could negatively impact these potential strength benefits and low blood glucose could lead to falls. As such, any exercise program that causes swings in glucose levels may hinder rather than help.
The goal of this study is to evaluate the effect of weightlifting over a 6-month timeframe on functional mobility in postmenopausal females with type 1 diabetes, compared to a group that does not train. the investigators will also assess its effects on blood sugar variability and the risk of hypoglycemia. Like different medications, not all exercise is equal. Creating more knowledge about the benefits of specific types of exercise in this population will allow us to be more precise in our exercise recommendations for living longer and more independently with type 1 diabetes.
Detailed description
Background: Type 1 diabetes, an autoimmune condition resulting in the near-absence of insulin secretion, requires lifelong exogenous insulin to manage blood glucose levels. Due to fear of hypoglycemia, which can be fatal, many people with type 1 diabetes maintain blood glucose levels slightly higher than the physiological range. This hyperglycemia is associated with many diabetes-related complications, including nephropathy, retinopathy, neuropathy and cardiovascular disease. It is also associated with an accelerated decrease in bone quality and muscle strength/quality with aging, creating a higher risk of age-related musculoskeletal fragility. The effects are more prominent in females than they are in males, particularly after menopause. As a result, postmenopausal females with type 1 diabetes have an especially high risk of frailty.
Frailty among older adults with type 1 diabetes is an important problem to address. With improvements in diabetes care/technology, people with type 1 diabetes are living longer, leading to a higher prevalence of type 1 diabetes among seniors. In older females without diabetes, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization and even death. These risks may be accentuated for postmenopausal females living with type 1 diabetes. Regular exercise helps to maintain the strength and quality of muscles and bones with aging. The best type of exercise to help maintain functional mobility in postmenopausal females with type 1 diabetes while not sacrificing tight glycemic management is currently unknown. Resistance exercise (weight lifting) helps prevent decreases in mobility in seniors without diabetes. In people with type 1 diabetes it is often associated with smaller blood glucose declines than aerobic exercise during activity, but has also been reported to increase blood glucose levels in some situations.
It may also increase hypoglycemia occurrence in the hours after exercise. Hyperglycemia could negatively affect potential strength benefits. Frequent hypoglycemia increases the risk of falls and injury. Unfortunately, most of the available data were collected on young, fit males, limiting our ability to create evidence-based exercise guidelines for healthful and independent aging for postemenopausal females with type 1 diabetes. As there are known sex-related differences in physiological exercise responses and gender-related differences in activity preferences, studying females and males separately is warranted.
Goal: The goal of the study is to create knowledge around resistance exercise effects on functional mobility in postmenopausal females with type 1 diabetes. The investigators will also assess their impact on 24-hour glycemia (continuous glucose monitoring), bone mineral density (DXA) and self-reported quality of life. Finally, the investigators will compare these outcomes to a group who did not exercise during the same time frame.
Methods/Approaches: To achieve this goal, the investigators will conduct a 6-month randomized controlled trial across three sites to assess the impact of supervised resistance exercise on functional mobility (timed up and go test) compared to no exercise in postmenopausal females with type 1 diabetes. The investigators will recruit postmenopausal females with type 1 diabetes who are not currently meeting physical activity guidelines. All participants will undergo a 4-week run-in period for exercise familiarization and diabetes care optimization, followed by 22 weeks of the assigned treatment. Measures will be taken before run-in and at the end of the intervention by personnel blinded to group assignment.
Expected Outcomes: This project will fill an important void in the information being used to produce evidence-based guildeines for people with type 1 diabetes by providing more precise advice for postmenopausal females with type 1 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise | Experimental | Behavioral: Resistance exerciseSupervised progressive resistance exercise training three times weekly |
| wait-list control | No intervention | –Usual care. Participants will be offered the training program at the end of the 6-month control period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) female
- 2) clinical diagnosis of T1D requiring continuous insulin therapy [(either by multiple daily injections or continuous subcutaneous insulin infusion (insulin pumps)] for > 1 yr
- 3) aged ≥60 yrs, or ≥50 yrs with signs or symptoms of clinical frailty (level 4 on the Clinical Frailty Scale)
- 4) physically inactive (<30 mins of aerobic activity <3x/week; no resistance exercise)
- 5) postmenopausal (no menstrual periods in the previous 12 months, or who have had a hysterectomy and bilateral salpingo-oophorectomy with ≥1 yr having elapsed since surgery)
Key exclusion criteria (13 listed)
- 1) unable to communicate in English/French
- 2) unwilling/unable to sign informed consent
- 3) having performed RT in the past 6 months
- 4) recent (last 3 months) or multiple episodes (>2 in last 12 months) of severe hypoglycemia and/or diabetic ketoacidosis
- 5) those with PA restrictions due to:
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 exerciseSupervised progressive resistance exercise | Behavioural | Resistance exercise |
Primary outcome
Change in the time (in seconds) taken to complete the timed up and go test test
Time frame: Baseline and 6 months (post-training)
The test begins with the participant sitting correctly in a chair with arms fixed (so as not to move when the participant stands), with her back resting on the back of the chair. When the timer says "Go" the participant will stand, walk to a line 3 metres away from the chair, turn around, walk back and sit down. The timing starts with "Go" and ends when the participant is seated.
4 secondary outcomes
change in 30-second chair stand test
Time frame: Baseline and 6 months (post-training)
Change in 6-minute walk test
Time frame: Baseline and 6 months (post-training)
Change in isometric grip strength
Time frame: Baseline and 6 months (post-training)
Eight repetition maximum (8RM) strength test
Time frame: Baseline and 6 months (post-training)
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 1 Oct 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.
Corinne Suppere, MSc contact
Jane E Yardley, PhD principal investigator
Institut de Recherches Cliniques de Montreal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Type 1 Diabetes (T1D) and Menopause, run by Institut de Recherches Cliniques de Montreal at 3 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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 (1-514-987-5568, jane.yardley@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the time (in seconds) taken to complete the timed up and go test test (time frame: Baseline and 6 months (post-training)). 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 1 Oct 2026.