DelfaGLP-1 Atlas

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MOTIVATE

Not yet recruitingPhase 4

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

Metabolic Optimization and Training InterVentions for Aging and Type 2 Diabetes to Enhance Cognition: the MOTIVATE Study

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

164

estimated

Study population

Type 2 diabetes

Key I/E criterion

•Age ≥65

Primary endpoint

•Trail Making Test (TMT) Part A and B

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07485062
Org study ID128008
Secondary ID528313Canadian Institutes of Health Research (CIHR)

Timeline

Milestones

Study first posted2026-03-20actual
Last update posted2026-03-20actual
Study start2026-05-01estimated
Primary completion2029-05-01estimated
Study completion2029-05-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
22
Other (unclassified)
7
Weight & body composition
5
Cardiometabolic biomarkers
5
Glycemic / diabetes
3
Heart failure
1
Renal / kidney
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Body Weight

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist-to-Hip Ratio (WHR)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

ratio, improvement

Other/protocol endpoint

Total Lean Body Mass (LBM)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

Lean mass

descriptive

Other/protocol endpoint

Body Fat Percentage (%BF)

Time frame:Baseline (0 weeks), Midpoint (16 weeks), Endpoint (32 weeks)

change from baseline, improvement

Other/protocol endpoint

Total Fat Mass (FM)

Time frame:Baseline (0 weeks), Midpoint (16 weeks), Endpoint (32 weeks)

Total fat mass

descriptive

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Fasting Blood Glucose (FBG) Measurement

Time frame:Baseline (Week 0), Midpoint (Week 16), Endpoint (Week 32)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Glycated Hemoglobin (HbA1c)

Time frame:Baseline (Week 0), Midpoint (Week 16), Endpoint (Week 32)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

Six-Minute Walk Test

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

6-minute walk distance

change from baseline, improvement

Renal / kidney

1 endpoint
Other/protocol endpoint

Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Low-Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

High-Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Total Triglycerides (TG)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Total Cholesterol (TC)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

C-reactive protein (CRP)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other clinical outcomes

22 endpoints
Primary/protocol endpoint/low confidence

Trail Making Test (TMT) Part A and B

Time frame:Baseline (Week 0), Midpoint (Week 16), Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

descriptive, improvement

Secondary/protocol endpoint

Mini-Mental State Examination (MMSE)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Digit Span (Forward and Backward)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Stroop Color-Word Test

Time frame:(Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Rey Auditory Verbal Learning Test (RAVLT)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Digit Symbol Substitution Test (DSST)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

NIH Toolbox Flanker Task

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

descriptive, improvement

Secondary/protocol endpoint

Timed Up and Go (TUG) Test

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Short Physical Performance Battery (SPPB)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Grip Strength Dynamometry

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

One-repetition maximum (1RM) strength testing

Time frame:Third Exercise Class, Midpoint (Week 16), and Endpoint (Week 32)

descriptive

Secondary/protocol endpoint

Mean Cortical Thickness

Time frame:Baseline (Week 0) and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

White Matter Fractional Anisotropy (FA)

Time frame:Baseline (Week 0) and Endpoint (Week 32)

change from baseline, descriptive

Secondary/protocol endpoint

Total Gray Matter & White Matter Volumes

Time frame:Baseline (Week 0) and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Subcortical Gray Matter Volume

Time frame:Baseline (Week 0) and Endpoint (Week 32)

change from baseline, descriptive

Secondary/protocol endpoint

White Matter Hyperintensity (WMH) Volume

Time frame:Baseline (Week 0) and Endpoint (Week 32)

change from baseline, improvement

Other/protocol endpoint

Bone Mineral Density (BMD)

Time frame:Baseline (0 weeks), Midpoint (16 weeks), Endpoint (32 weeks)

change from baseline, descriptive

Other/protocol endpoint

Gait Velocity (Walking Speed)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Other/protocol endpoint

Stride Time Variability (Coefficient of Variation)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

ratio, improvement

Other/protocol endpoint

Double Support Time (% of Gait Cycle)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

descriptive, improvement

Other (unclassified)

7 endpoints
Secondary/protocol endpoint/low confidence

Resting-state functional connectivity

Time frame:Baseline (Week 0) and Endpoint (Week 32)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Brain-Derived Neurotrophic Factor (BDNF)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Insulin-like Growth Factor-1 (IGF-1)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum Interleukin-6 (IL-6)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

change from baseline, improvement

Secondary/protocol endpoint

Plasma Neurofilament Light (NfL)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Plasma p-tau181

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Amyloid Beta Ratio (beta42/40)

Time frame:Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32)

ratio, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.