Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes
NCT07485062, Phase 4, Not yet recruiting, Western University, Canada
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes | ClinicalTrials.gov |
| NCT number | NCT07485062 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 164 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Western University, Canada | ClinicalTrials.gov |
| Conditions | Type 2 Diabetes, Cognitive Decline in Older Adults | ClinicalTrials.gov |
| Interventions | semaglutide, Moderate-Intensity Resistance Exercise, Balance and Tone (BAT) Exercise | ClinicalTrials.gov |
| First posted | 2026-03-20 | ClinicalTrials.gov |
| Last updated | 2026-08-20 | ClinicalTrials.gov |
Registered outcomes 44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Trail Making Test (TMT) Part A and B | Baseline (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. | ClinicalTrials.gov |
| Secondary | Montreal Cognitive Assessment (MoCA) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | 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). | ClinicalTrials.gov |
| Secondary | Mini-Mental State Examination (MMSE) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | 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. | ClinicalTrials.gov |
| Secondary | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | 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. | ClinicalTrials.gov |
| Secondary | Digit Span (Forward and Backward) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | 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. | ClinicalTrials.gov |
| Secondary | Stroop Color-Word Test | (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | Assesses selective attention, processing speed, and cognitive inhibition. Participants are required to identify ink colors while inhibiting automatic word reading. Completion time and/or errors are recorded. Faster completion times and fewer errors indicate better performance. | ClinicalTrials.gov |
| Secondary | Rey Auditory Verbal Learning Test (RAVLT) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | A measure of episodic verbal learning and memory. Participants are read a list of words across multiple trials and asked to recall as many words as possible immediately and after a delay. The total number of words recalled immediately and after a delay is recorded. Additionally, a learning rate is calculated across the number of trials. More words recalled and faster learning rates indicate better performance. | ClinicalTrials.gov |
| Secondary | Digit Symbol Substitution Test (DSST) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | Administered using Inquisit software (Millisecond Software) using a computer, this is a timed task assessing processing speed, attention, and visuomotor coordination. Participants use a reference key to match symbols with corresponding numbers within a fixed time period. Total correct responses are recorded. Greater correct responses correspond with better performance. | ClinicalTrials.gov |
| Secondary | NIH Toolbox Flanker Task | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | A computerized task assessing attention and inhibitory control. Participants respond to the direction of a central target stimulus while ignoring flanking distractors. The task is administered via the NIH Toolbox platform using a touchscreen or keyboard response on a tablet or computer device. Reaction time and accuracy are automatically recorded. Faster reaction times and greater accuracy correspond with better performance. | ClinicalTrials.gov |
| Secondary | Timed Up and Go (TUG) Test | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | Used to assess mobility. Participants are seated in a chair and must stand up, walk a distance of 3 meters at their usual pace, turn around, return to their chair, and sit back down. The time to complete each of two separate trials is recorded in seconds. | ClinicalTrials.gov |
| Secondary | Short Physical Performance Battery (SPPB) | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | Used to assess gait speed, balance, and lower extremity physical function using tasks that mimic daily activities; includes three tasks: (1) Standing Balance Task: participants stand unassisted (side-by-side standing, semi-tandem standing, and tandem standing) for a period of 10 seconds each; (2) Walking Speed Task: participants walk 4 meters at their usual pace; and (3)Chair Stand Test: participants stand up from a chair 5 times consecutively (without the use of their arms if possible). Time to complete tasks 2 and 3 is recorded in seconds. A score between 0 and 12 is assigned based on the above measures. A higher score indicates better daily physical function. | ClinicalTrials.gov |
| Secondary | Six-Minute Walk Test | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | Used to assess aerobic fitness. Participants walk the furthest distance they can achieve in a total of 6 minutes. The total distance walked in meters is recorded. The greater the distance, the better aerobic fitness. | ClinicalTrials.gov |
| Secondary | Grip Strength Dynamometry | Baseline (Week 0), Midpoint (Week 16), and Endpoint (Week 32) | Grip strength will be assessed using a calibrated handheld dynamometer to measure maximal voluntary isometric force of the dominant hand, providing an index of overall muscular strength. Measured in kgs. | ClinicalTrials.gov |
| Secondary | One-repetition maximum (1RM) strength testing | Third Exercise Class, Midpoint (Week 16), and Endpoint (Week 32) | One-repetition maximum is a physical measure of an individual's maximum muscle strength during a single repetition and is used to determine the desired load for resistance training. Exercise includes leg press, latissimus pulldown, leg curl, chest press, bicep curls, tricep extensions, and pulley rows. Measured in kgs. | ClinicalTrials.gov |
| Secondary | Mean Cortical Thickness | Baseline (Week 0) and Endpoint (Week 32) | The average distance between the white matter surface and the pial (outer) surface across the entire cerebral cortex and by region. Automated vertex-wise calculation of the distance between the gray/white matter boundary and the gray matter/CSF boundary. Millimeters (mm). Greater thickness is typically better. | ClinicalTrials.gov |
| Secondary | Resting-state functional connectivity | Baseline (Week 0) and Endpoint (Week 32) | Participants will be asked to remain as still as possible with eyes open while a functional scan is acquired to assess intrinsic resting-state brain networks. Measured as Fisher-z transformed correlation coefficients (z). Higher values represent stronger functional synchronization. | ClinicalTrials.gov |
| Secondary | White Matter Fractional Anisotropy (FA) | Baseline (Week 0) and Endpoint (Week 32) | A diffusion tensor imaging metric that measures the "directionality" of water diffusion within white matter tracts. It reflects the organization and integrity of the myelin and axonal membranes. Calculated from the diffusion tensor at each voxel; typically averaged across major tracts (e.g., Corpus Callosum, Cingulum). Values: Scale from 0 to 1 (unitless). A value of 1 indicates perfectly directional diffusion (healthy, organized white matter), while a decrease in FA indicates axonal degradation, demyelination, or "leaky" white matter. | ClinicalTrials.gov |
| Secondary | Total Gray Matter & White Matter Volumes | Baseline (Week 0) and Endpoint (Week 32) | The global volume of the brain's neuronal cell bodies (gray matter) and myelinated axons (white matter) using automated whole-brain segmentation. Measured in cubic millimeters (mm\^3). Reduced total gray matter volume indicates global atrophy. White matter volume changes can indicate loss of structural connectivity. | ClinicalTrials.gov |
| Secondary | Subcortical Gray Matter Volume | Baseline (Week 0) and Endpoint (Week 32) | The total volume of deep brain structures, most notably the hippocampus, thalamus, and amygdala using automated whole-brain segmentation. Measured in cubic millimeters (mm\^3). Reduced volume typically indicates brain atrophy. | ClinicalTrials.gov |
| Secondary | White Matter Hyperintensity (WMH) Volume | Baseline (Week 0) and Endpoint (Week 32) | A measure of "leukoaraiosis" or white matter lesions, which appear as bright spots on T2-weighted magnetic resonance imaging (MRI) scans. These are primary markers of small vessel disease and vascular brain aging. Automated or semi-automated segmentation (e.g., via FreeSurfer's aseg or specialized toolboxes like BIANCA/LST) on T2- images. Measured as total volume in cubic millimeters (mm\^3) or as a percentage of Total Intracranial Volume (%ICV). Lower is better. Higher WMH volumes are strongly associated with hypertension, diabetes, and increased risk for stroke and vascular dementia. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Eriksen Flanker Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)