An interventional study of Resistance exercise in Type 1 Diabetes (T1D) and Menopause, sponsored by Institut de Recherches Cliniques de Montreal. Not yet recruiting at 3 sites in Canada. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Institut de Recherches Cliniques de Montreal · Not applicable, Interventional, and Prevention
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 63 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supervised progressive resistance exercise training three times weekly
Behavioral: Resistance exercise
Usual care. Participants will be offered the training program at the end of the 6-month control period.
Supervised progressive resistance exercise
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.
Time frame: Baseline and 6 months (post-training)
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline and 6 months (post-training)
Bone density
Measured using dual x-ray absorptiometry
Time frame: Baseline and 6 months (post-training)
Lean body mass
Measured by dual x-ray absorptiometry
Time frame: Baseline and 6 months (post-training)
Short Form-36 Health Survey
The questionnaire contains 36 items that assess 8 health domains: 1) Physical functioning, 2) role limitations due to physical health, 3) bodily pain, 4) general health perceptions, 5) vitality, 6) social functioning, 7) role limitations due to emotional problems, and 8) mental health. Each domain is scored from 0 to 100 with higher scores indicating better health status.
Time frame: Baseline and 6 months (post-training)
Diabetes-Specific Quality of Life Questionnaire (DSQOL)
This is a patient-reported questionnaire designed to assess how living with type 1 diabetes affects quality of life. The English-language validated survey contains six factors: social aspects, fear of hypoglycemia, dietary restrictions, physical complaints, anxiety about the future and daily hassles. It contains 64 items with multiple subscales with respondents rating statements using a 1 to 6-point Likert-type response scale. Subscale scores are calculated separately. Higher scores generally indicate better diabetes-specific quality of life and greater treatment satisfaction.
Time frame: Baseline and 6 months (post-training)
Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1)
This questionnaire assesses perceived barriers to engaging in regular physical activity among adults with type 1 diabetes. It contains 12 items, each rated on a 1 to 7-point Likert scale. Higher scores indicate that the item is more likely to be a barrier to physical activity for the individual.
Time frame: Baseline and 6 months (post-training)
Diabetes Distress Scale (DDS-17)
The survey contains 17 items, each rated on a scale of 1 (not a problem) to 6 (very serious problem). The four domains include emotional burden, regimen distress, physical-related distress, and interpersonal distress. The overall score is calculated by dividing the sum of the items scored by the total number of items, providing an overall score between 1 (no distress) and 6 (high distress).
Time frame: Baseline and 6 months (post-training)
Katz Index of Independence in Activities of Daily Living
The questionnaire evaluates functional status by assessing independence in six basic activities: bathing, dressing, toileting, transferring (moving between bed and chair), continence and feeding. Each activity is scored as 1 (independent) or 0 (requires assistance or complete help). The scores are summed to produce a total score from 0 to 6, with 0-1 being severely dependent, and 6 being fully independent.
Time frame: Baseline and 6 months (post-training)
Clarke Hypoglycemia Awareness Questionnaire (Clarke Score)
This is an 8-item questionnaire used to assess impaired awareness of hypoglycemia in people with type 1 diabetes. It contains 8 questions addressing: recognition of hypoglycemia symptoms, loss of warning symptoms over time, frequency of moderate hypoglycemic episodes, frequency of severe hypoglycemic episodes, frequency of symptomatic hypoglycemia, frequency of asymptomatic hypoglycemia, glucose level at which symptoms are perceived and confidence in recognizing low glucose levels by symptoms. Answers are classified as A (aware) or R (reduced awareness). A lower number of R scores indicates better awareness. A score of 4 or greater is considered clinically significant impaired awareness of hypoglycemia.
Time frame: Baseline and 6 months (post-training)
Pittsburgh Sleep Quality Index
The PSQI measures an individual's perception of their sleep quality over the previous month. It contains 19 self-rated questions. It contains 7 component scores, each ranging from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to create a global score ranging from 0 to 21, with lower scores indicating better sleep quality.
Time frame: Baseline and 6 months (post-training)
Diet
3-day food diary
Time frame: Week 3, 15, and 26
Background physical activity
7-day accelerometry measures
Time frame: weeks 3, 15, and 26
insulin dose
self-reported
Time frame: weeks 3, 15, 26
changes in medication (other than insulin)
self-reported changes in medication
Time frame: weeks 3, 15, 26
glucose time in range
measured by continuous glucose monitoring
Time frame: once per week between weeks 1 and 26
glucose time below range
continuous glucose monitoring
Time frame: once per week between weeks 1 and 26
level 1 hypoglycemia
continuous glucose monitoring
Time frame: once per week between weeks 1 and 26
level 2 hypoglycemia
measured by continuous glucose monitoring
Time frame: once per week between weeks 1 and 26
Severe hypoglycemia (level 3)
continuous glucose monitoring
Time frame: once per week between weeks 1 and 26
time above range
continous glucose monitoring
Time frame: once per week between weeks 1 and 26
Glycemic variability
continuous glucose monitoring
Time frame: once per week between weeks 1 and 26
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Institut de Recherches Cliniques de Montreal