Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes

Sponsor
Western University, Canada
Study ID
NCT07485062
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    Injectable semaglutide administered once weekly by subcutaneous injection for 16 weeks, as prescribed and monitored by the study physician.
  • Moderate-Intensity Resistance Exercise — BEHAVIORAL
    Supervised moderate-intensity resistance exercise training performed three times per week for 32 weeks.
  • Balance and Tone (BAT) Exercise — BEHAVIORAL
    Supervised balance-and-tone (BAT) exercise performed three times per week for 32 weeks, serving as an active control exercise condition.

Study Details

Type 2 diabetes and low levels of physical activity are associated with an increased risk of cognitive decline in older adults. Improving blood sugar control and engaging in regular exercise may help support brain health and physical function in this population. The MOTIVATE study is a randomized clinical trial designed to examine the effects of supervised exercise and diabetes treatment with semaglutide, alone or in combination, on cognitive function, physical health, and brain-related outcomes in older adults with Type 2 diabetes. Participants will be assigned to one of four study groups involving exercise training, control exercise, semaglutide treatment, or standard diabetes care. Participants will complete supervised exercise sessions three times per week for 32 weeks, with some participants also receiving weekly semaglutide injections for 16 weeks. Assessments will include cognitive testing, physical and functional measures, blood-based metabolic markers, and brain imaging. This study aims to improve understanding of how exercise and diabetes treatments may support brain health in older adults with Type 2 diabetes.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Resistance Exercise + Semaglutide
    Participants assigned to this arm will receive injectable semaglutide once weekly for 16 weeks, in addition to participating in supervised moderate-intensity resistance exercise training three times per week for 32 weeks. Semaglutide will be administered during the first 16 weeks, followed by a 16-week exercise-only period.
  • Active Comparator: Standard of Care + Resistance Exercise
    Participants assigned to this arm will receive standard of care treatment for Type 2 diabetes for 16 weeks and participate in supervised moderate-intensity resistance exercise training three times per week for 32 weeks. No semaglutide will be administered during the study period.
  • Active Comparator: Semaglutide + Balance and Tone Exercise
    Participants assigned to this arm will receive injectable semaglutide once weekly for 16 weeks and participate in supervised balance-and-tone (BAT) exercise three times per week for 32 weeks. Semaglutide will be administered during the first 16 weeks, followed by a 16-week exercise-only period.
  • Active Comparator: Standard of Care + Balance and Tone Exercise
    Participants assigned to this arm will receive standard of care treatment for Type 2 diabetes for 16 weeks and participate in supervised balance-and-tone (BAT) exercise three times per week for 32 weeks. No semaglutide will be administered during the study period.

Primary Outcome Measure

Trail Making Test (TMT) Part A and B [ Time Frame: Baseline (Week 0), Midpoint (Week 16), Endpoint (Week 32) ]

Central Contacts

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