Semaglutide + Exercise for Type 2 Diabetes

(MOTIVATE Trial)

Overseen By Olivia Ghosh-Swaby, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Western University, Canada

Must be taking: Semaglutide

Must not be taking: GLP-1 agonists, Psychotropics

Disqualifiers: Neurodegenerative disease, Untreated depression, Recent vascular incident, Severe neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Informed consent obtained before any trial-related activities

Community-dwelling

Score >24/30 on the Mini-Mental State Exam (MMSE)

Exclusion Criteria

I am taking medications for mental health conditions other than depression.

Have engaged regularly (>1/week) in aerobic or resistance exercise within the past 6 months

Have a neurodegenerative disease (i.e., dementia) or psychiatric condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive supervised exercise sessions three times per week for 32 weeks, with some receiving weekly semaglutide injections for 16 weeks

32 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Balance and Tone (BAT) Exercise
• Moderate-Intensity Resistance Exercise
• Semaglutide

How Is the Trial Designed?

Group I: Resistance Exercise + Semaglutide Experimental Treatment 2 Interventions

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.

Group II: Standard of Care + Resistance Exercise Active Control 1 Intervention

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.

Group III: Semaglutide + Balance and Tone Exercise Active Control 2 Interventions

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.

Group IV: Standard of Care + Balance and Tone Exercise Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+