Clinical trial

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

Opening soon · Phase 4 · 1 countries · Registry ID NCT07485062

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age65 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Cognitive Decline in Older Adults

Full registry criteria

Inclusion Criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Community-dwelling 3. Male or female 4. Age ≥ 65 at the time of signing informed consent 5. Glycated hemoglobin levels of ≥7% (i.e., A1c levels high enough to see intervention-related changes and increase eligibility for recruitment, but can exercise safely) 6. Eligible for the Ontario Drug Benefit (inadequate glycemic control and on max tolerated dose of metformin or metformin contraindicated or inappropriate) 7. Score \>24/30 on the Mini-Mental State Exam (MMSE) 8. Score \>6/8 on the Lawton Instrumental Activities of Daily Living Scale (IADL) 9. Have visual acuity of \>20/40 with or without corrective lenses 10. Speak and understand English fluently 11. Complete the Physical Activity Readiness Questionnaire (PAR-Q+) and obtain physician clearance to start a supervised exercise program 12. Comfortable with a blood draw 13. Not currently engaging in structured resistance exercise more than once per week Exclusion Criteria: 1. Have a medical condition for which semaglutide or exercise is contraindicated 2. Use of a GLP-1 receptor agonist in the past 6 months (i.e., offers removal of Semaglutide from the system as it has a half-life of around 1 week; thus, 8-10 weeks are required for a washout. 3\) Have engaged regularly (\>1/week) in aerobic or RE within the past 6 months 4) Have a neurodegenerative disease (i.e., dementia) or psychiatric condition 5) Have had untreated depression in the past 6 months (6) Have experienced a recent vascular incident (i.e., stroke, myocardial infarction in the last 6 months.) (7) Have severe peripheral neuropathy, an active foot wound, or severe musculoskeletal/joint disease (8) Active or untreated retinopathy (9) Taking psychotropic medications (excluding those for the treatment of depression)

Treatments and study arms

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.

Primary outcomes

Trail Making Test (TMT) Part A and BBaseline (Week 0), Midpoint (Week 16), Endpoint (Week 32)

Executive function will be assessed using the Trail Making Test (TMT), Parts A and B. The TMT measures visual attention, processing speed (Part A), and executive function/set-shifting ability (Part B). Time to completion (seconds) will be recorded, with faster completion times indicating better performance.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Western University🇨🇦 London, Ontario, Canada

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Olivia Ghosh-Swaby, PhDContact

Email · Call 5196612111