Incretin Therapy and Exercise in Type 2 Diabetes
ConditionType 2 Diabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina
About this trial
This study will examine changes in brain and physical health in adults with type 2 diabetes who are initiating incretin-mimetic therapy (e.g., Ozempic, Mounjaro), and determine whether adding structured exercise provides additional benefits. Participants will be randomized to receive incretin-mimetic therapy alone or incretin-mimetic therapy plus a structured exercise program for 24 weeks. If the participant is randomly assigned to the incretin-based therapy alone group, they will have the opportunity to complete the same structured exercise program after the 24-week study period is complete.
Brain health will be assessed through cognitive performance, mental health, and brain-mediated appetite regulation. The study will also assess gut microbiota and motor-cortex neuroplasticity as potential factors associated with changes in brain health, as well as glucose regulation, body composition, physical function, and cardiorespiratory fitness. Assessments will be completed at baseline, 8 weeks, and 24 weeks. Findings will help determine how incretin-mimetic therapy and exercise can be integrated to support brain and physical health in adults with type 2 diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults aged 18 years or older
diagnosed with pre diabetes or type 2 diabetes
prescribed incretin-based therapy (e.g., semaglutide or tirzepatide)
able and willing to participate in the study assessments and, if randomized to the exercise group, the 24-week structured exercise program
Disqualifiers
current use of incretin-based therapy outside the study-defined enrollment window
pregnant or planning to become pregnant during the study period
any other medical condition or circumstance that, in the opinion of the research team, would interfere with safe participation or completion of study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Exercise Program
BehavioralA 24-week individualized exercise program consisting of three exercise sessions per week. The program will include resistance and aerobic exercise based on Canadian physical activity guidelines, with exercise selection and intensity adjusted to individual abilities and fitness levels. Two sessions per week will be supervised at the University of Regina and one session per week will be completed independently. Each session will last approximately 60-90 minutes. Participants will also receive guidance on adequate protein intake.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Incretin Therapy AloneNo intervention 0 interventions
Group B: Incretin Therapy plus ExerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in insulin resistance (HOMA-IR)
Insulin resistance will be estimated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin concentrations. Higher HOMA-IR values indicate greater insulin resistance. The primary outcome will be the between-group difference in change in HOMA-IR from baseline to 24 weeks.
Time frame
Baseline, 8 weeks, and 24 weeksSecondary outcomes
1
Change in Eating Patterns and Behaviours
Eating patterns and behaviours will be assessed using validated questionnaires examining dietary quality, eating behaviours, appetite, and food cravings. Questionnaire scores will be calculated according to established scoring procedures, with changes assessed over the 24-week intervention.
Time frame
Baseline, 8 weeks, and 24 weeks2
Change in cardiovascular health
Resting heart rate variability will be assessed from beat-to-beat cardiac recordings. Heart rate variability will be quantified using prespecified time-domain measures of variation in successive heartbeats. Arterial stiffness will be assessed using pulse wave velocity (PWV), which measures the speed at which the arterial pressure wave travels between two arterial sites. PWV will be expressed in metres per second (m/s), with higher values indicating greater arterial stiffness.
Time frame
Baseline, 8 weeks, and 24 weeks3
Change in body composition
Fat- and fat free mass will be assessed using air-displacement plethysmography (BodPod) and expressed in kilograms (kg).
Time frame
Baseline, 8 weeks, and 24 weeks4
Change in physical function
Maximal isometric handgrip strength will be assessed using a handgrip dynamometer. The highest force produced during standardized maximal handgrip attempts will be recorded. Lower-body physical function will be assessed using the 30-second sit-to-stand test. Participants will be instructed to complete as many full sit-to-stand repetitions as possible in 30 seconds. Performance will be expressed as the total number of successfully completed repetitions.
Time frame
Baseline, 8 weeks, and 24 weeksOther outcomes
1
Change in gut microbiota
Gut microbiota will be assessed from stool samples using 16S ribosomal RNA (rRNA) gene sequencing. Changes in gut microbial composition will be characterized using measures of within-sample diversity (alpha diversity), between-sample community composition (beta diversity), and the relative abundance of bacterial taxa. Alpha diversity will be assessed using the Shannon diversity index, and beta diversity will be assessed using prespecified ecological distance measures. Changes in the relative abundance of bacterial taxa will be assessed at relevant taxonomic levels.
Time frame
Baseline, 8 weeks, and 24 weeks2
Change in motor cortical neuroplasticity
Motor cortical neuroplasticity will be assessed using transcranial magnetic stimulation (TMS). Motor-evoked responses will be measured before and after a brief period of intermittent theta-burst stimulation (iTBS). Neuroplasticity will be quantified as the change in motor-evoked responses following iTBS relative to responses measured before iTBS
Time frame
Baseline, 8 weeks, and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov
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