Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorWestern University, Canada
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Community-dwelling
Male or female
Age ≥ 65 at the time of signing informed consent
Disqualifiers
Have a medical condition for which semaglutide or exercise is contraindicated
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.
Trial design
Design model
Factorial
Treatments tested in this trial
semaglutide
DrugInjectable semaglutide administered once weekly by subcutaneous injection for 16 weeks, as prescribed and monitored by the study physician.
Moderate-Intensity Resistance Exercise
BehavioralSupervised moderate-intensity resistance exercise training performed three times per week for 32 weeks.
Balance and Tone (BAT) Exercise
BehavioralSupervised balance-and-tone (BAT) exercise performed three times per week for 32 weeks, serving as an active control exercise condition.
Treatment groups
164 Participants
are divided into 4 treatment groupsGroup A: Resistance Exercise + SemaglutideExperimental treatment 2 interventions
Group B: Standard of Care + Resistance ExerciseActive comparator 1 intervention
Group C: Semaglutide + Balance and Tone ExerciseActive comparator 2 interventions
Group D: Standard of Care + Balance and Tone ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Trail Making Test (TMT) Part A and B
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.
Time frame
Baseline (Week 0), Midpoint (Week 16), Endpoint (Week 32)Secondary outcomes
1
Montreal Cognitive Assessment (MoCA)
A 30-point cognitive screening tool designed to detect mild cognitive impairment. Domains assessed include attention, executive function, memory, language, visuoconstructional skills, abstraction, calculation, and orientation. Measurement Scale: Total scores range from 0 to 30. Higher scores indicate better cognitive performance. For this study, a score of ≥26 is considered "normal" cognitive function, while scores below this threshold (typically 18-25) may suggest mild cognitive impairment (MCI).
Time frame
Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)2
Mini-Mental State Examination (MMSE)
An 11-item screening tool assessing global cognitive function across orientation, registration, attention and calculation, recall, and language. Scores range from 0-30, with higher scores indicating better cognitive function.
Time frame
Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)3
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11)
A cognitive test with an 11-task battery assessing memory, language, praxis, attention, and orientation. Widely used in clinical trials to evaluate cognitive dysfunction and disease progression in Alzheimer's disease and related conditions. A score ranges from 0 to 70. Higher scores represent greater cognitive deficit (impairment), with scores of 18 or higher typically indicating cognitive impairment.
Time frame
Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)4
Digit Span (Forward and Backward)
A measure of working memory requiring participants to recall increasingly long sequences of numbers in both forward and reverse order. The final score is usually the total correct sequences (0-14 correct) and the longest sequence length achieved (e.g., if a user correctly repeats a 7-digit string, their span is 7). A minimum sequence length of 3 (forward) or 2 (backward) and a maximum sequence of 9 (forward) or 8 (backward) can be achieved. High scores indicate better performance.
Time frame
Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)Other outcomes
1
Total Lean Body Mass (LBM)
Total non-fat, non-bone tissue mass as measured by a whole-body dual-energy X-ray absorptiometry (DEXA) scan.
Time frame
Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)2
Body Fat Percentage (%BF)
The proportion of total fat mass relative to total body mass, calculated via whole-body DEXA scan. Unit of Measure: Percentage (%)
Time frame
Baseline (0 weeks), Midpoint (16 weeks), Endpoint (32 weeks)3
Bone Mineral Density (BMD)
Total body bone mineral density is determined by the attenuation of two X-ray beams of different energy levels. Unit of Measure: (g/cm\^2) (Grams per square centimeter)
Time frame
Baseline (0 weeks), Midpoint (16 weeks), Endpoint (32 weeks)4
Total Fat Mass (FM)
Total body fat tissue mass as measured by a whole-body DEXA scan. Unit of Measure: Kilograms (kg)
Time frame
Baseline (0 weeks), Midpoint (16 weeks), Endpoint (32 weeks)Sponsors and contacts
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Source ClinicalTrials.gov
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