NCT07851662Not yet recruiting
Functional Mobility and Resistance Exercise for Postmenopausal Females With Type 1 Diabetes
A Randomized Controlled Trial of Functional MobiLity and Resistance EXercise for Postmenopausal Females With Type 1 Diabetes: the FLEX-T1D Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 21 Sept 2026
- Start date
- Dec 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Diseases
- Type 1 diabetes
- NCT number
- NCT07851662
What you commit to
- Study type: Interventional
- Planned participants: 63
- From Dec 2026 to the primary completion date, Sept 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- d) unstable cardiac or pulmonary disease
- e) disabling stroke
- g) uncontrolled hypertension (BP\>150 mmHg systolic or \>95 mmHg diastolic while seated)
Lab values
- f) significant renal disease (estimated GFR\<25 mL/min/1.73 m2 or urine albumin/creatinine ratio \>150 mg/mmol)
Other
- 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
- b) severe peripheral neuropathy
- c) active proliferative retinopathy
- h) musculoskeletal injury, foot wound or amputation that would affect the ability to exercise
Who the study is looking for
- 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)
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alberta Diabetes Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| McMaster University Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Institut de Recherches Cliniques de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.