Type 2 Diabetes MellitusBIOMNCT07833813
Incretin Therapy and Exercise in Type 2 Diabetes
A study testing Structured Exercise Program in people with Type 2 Diabetes Mellitus, run by University of Regina at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Structured Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- able to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shivangi Sharma, BSc contact
Canada1 site
Centre for Kinesiology
Regina, Saskatchewan, S4S 0A2
Julia Totosy de Zepetnek, PhD, 306-585-4370, julia.totosy@uregina.ca
About this study
Official title: Effects of Incretin Memetics and Exercise on Gut-brain and Metabolic Health in Persons With Type 2 Diabetes
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.
Read the detailed description
Type 2 diabetes (T2D) is associated with alterations in cognitive function, mental health, and the regulation of appetite and food intake. Incretin-mimetic therapies are increasingly used in the management of T2D and improve glycemic control while reducing appetite and body mass. However, their effects on brain health remain poorly understood. In addition, body mass loss during incretin-mimetic therapy can include loss of lean tissue, which may have implications for metabolic health and physical function. Exercise is a cornerstone of T2D management and has beneficial effects on glycemic control, body composition, physical function, cognitive function, and mental health. Whether structured exercise provides additional brain-health benefits during incretin-mimetic therapy while helping to preserve lean tissue and physical function remains unclear.
The primary objective of this randomized controlled trial is to characterize changes in brain health during incretin-mimetic therapy and determine whether the addition of structured exercise provides additional benefit. Brain health will be considered across three complementary domains: cognitive performance, mental health, and brain-mediated appetite regulation. The study will also examine changes in body composition and metabolic and physical health to determine whether exercise helps preserve lean tissue and physical function during incretin-mimetic therapy.
A secondary objective is to investigate the microbiota-gut-brain axis (MGBA) and motor-cortex neuroplasticity as potential mechanistic correlates of brain-health responses. The MGBA represents bidirectional communication between the gut and brain and may influence cognitive and mental health as well as homeostatic and hedonic regulation of food intake. Gut microbial communities will be characterized using 16S rRNA gene sequencing and bioinformatics to examine changes in microbial diversity and composition.
Motor-cortex neuroplasticity will be assessed using transcranial magnetic stimulation (TMS). A standardized stimulation protocol will be used to induce changes in motor-cortex excitability, with changes in motor-evoked responses used to quantify the neuroplastic response. These measures will be used to investigate whether changes in motor-cortex neuroplasticity are associated with changes in brain-health outcomes.
Together, the study will examine the complementary effects of pharmacological and exercise-based approaches to T2D management and investigate biological factors that may contribute to brain-health responses during treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Structured Exercise Program
- Keywords
- incretin therapy, exercise, brain health, appetite regulation, microbiota-gut-brain-axis
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise ProgramBehavioural
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Incretin Therapy Alone | No intervention | Participants will receive incretin-based therapy prescribed by their healthcare provider as part of their usual clinical care. No structured exercise intervention will be provided by the research team during the 24-week study period. Participants will complete study assessments at baseline, 8 weeks, and 24 weeks. Following completion of the 24-week study period, participants will have the opportunity to complete the structured exercise program. |
| Incretin Therapy plus Exercise | Experimental | Participants will receive incretin-based therapy prescribed by their healthcare provider as part of their usual clinical care and will complete a 24-week structured exercise program. The exercise program will include resistance and aerobic exercise performed three times per week, with exercise type and intensity individualized to participants' abilities and fitness levels. Two sessions per week will be completed at the University of Regina under supervision, and one session per week will be completed independently. Participants will also receive guidance on adequate protein intake. Study assessments will be completed at baseline, 8 weeks, and 24 weeks. Receives: Behavioral: Structured Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, and 24 weeks
Secondary outcomes (5)
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.
Measured: Baseline, 8 weeks, and 24 weeks
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.
Measured: Baseline, 8 weeks, and 24 weeks
Change in body composition
Fat- and fat free mass will be assessed using air-displacement plethysmography (BodPod) and expressed in kilograms (kg).
Measured: Baseline, 8 weeks, and 24 weeks
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.
Measured: Baseline, 8 weeks, and 24 weeks
Change in aerobic fitness
Cardiorespiratory fitness will be assessed during a graded exercise test to volitional exhaustion. Peak oxygen uptake (VO₂peak) will be determined from expired respiratory gases and expressed relative to body mass as mL·kg-¹·min-¹. Higher values indicate greater cardiorespiratory fitness.
Measured: Baseline, 8 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with type 2 diabetes initiating incretin-based therapy will be randomized to either incretin-based therapy alone or incretin-based therapy plus a structured exercise program. Outcomes will be assessed at baseline, 8 weeks, and 24 weeks after starting the incretin therapy.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Totosy de Zepetnek, University of Regina
- Investigators
- Julia Totosy de Zepetnek, PhD, Principal investigator, Univeristy of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833813
- Sponsor's protocol ID
- REB 2026-2006
- Acronym
- BIOM
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications arising from this study may be made available to qualified researchers upon reasonable request and following appropriate ethical and institutional approvals.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Incretin Memetics and Exercise on Gut-brain and Metabolic Health in Persons With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07833813
- Acronym / sponsor ID
- BIOM / REB 2026-2006
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- incretin therapy, exercise, brain health, appetite regulation, microbiota-gut-brain-axis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes (T2D) is associated with alterations in cognitive function, mental health, and the regulation of appetite and food intake. Incretin-mimetic therapies are increasingly used in the management of T2D and improve glycemic control while reducing appetite and body mass. However, their effects on brain health remain poorly understood. In addition, body mass loss during incretin-mimetic therapy can include loss of lean tissue, which may have implications for metabolic health and physical function. Exercise is a cornerstone of T2D management and has beneficial effects on glycemic control, body composition, physical function, cognitive function, and mental health. Whether structured exercise provides additional brain-health benefits during incretin-mimetic therapy while helping to preserve lean tissue and physical function remains unclear.
The primary objective of this randomized controlled trial is to characterize changes in brain health during incretin-mimetic therapy and determine whether the addition of structured exercise provides additional benefit. Brain health will be considered across three complementary domains: cognitive performance, mental health, and brain-mediated appetite regulation. The study will also examine changes in body composition and metabolic and physical health to determine whether exercise helps preserve lean tissue and physical function during incretin-mimetic therapy.
A secondary objective is to investigate the microbiota-gut-brain axis (MGBA) and motor-cortex neuroplasticity as potential mechanistic correlates of brain-health responses. The MGBA represents bidirectional communication between the gut and brain and may influence cognitive and mental health as well as homeostatic and hedonic regulation of food intake. Gut microbial communities will be characterized using 16S rRNA gene sequencing and bioinformatics to examine changes in microbial diversity and composition.
Motor-cortex neuroplasticity will be assessed using transcranial magnetic stimulation (TMS). A standardized stimulation protocol will be used to induce changes in motor-cortex excitability, with changes in motor-evoked responses used to quantify the neuroplastic response. These measures will be used to investigate whether changes in motor-cortex neuroplasticity are associated with changes in brain-health outcomes.
Together, the study will examine the complementary effects of pharmacological and exercise-based approaches to T2D management and investigate biological factors that may contribute to brain-health responses during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with type 2 diabetes initiating incretin-based therapy will be randomized to either incretin-based therapy alone or incretin-based therapy plus a structured exercise program. Outcomes will be assessed at baseline, 8 weeks, and 24 weeks after starting the incretin therapy.
| Arm | Type | Receives |
|---|---|---|
| Incretin Therapy Alone | No intervention | –Participants will receive incretin-based therapy prescribed by their healthcare provider as part of their usual clinical care. No structured exercise intervention will be provided by the research team during the 24-week study period. Participants will complete study assessments at baseline, 8 weeks, and 24 weeks. Following completion of the 24-week study period, participants will have the opportunity to complete the structured exercise program. |
| Incretin Therapy plus Exercise | Experimental | Behavioral: Structured Exercise ProgramParticipants will receive incretin-based therapy prescribed by their healthcare provider as part of their usual clinical care and will complete a 24-week structured exercise program. The exercise program will include resistance and aerobic exercise performed three times per week, with exercise type and intensity individualized to participants' abilities and fitness levels. Two sessions per week will be completed at the University of Regina under supervision, and one session per week will be completed independently. Participants will also receive guidance on adequate protein intake. Study assessments will be completed at baseline, 8 weeks, and 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- able to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Exercise ProgramA 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. | Behavioural | Incretin Therapy plus Exercise |
Primary outcome
Change in insulin resistance (HOMA-IR)
Time frame: Baseline, 8 weeks, and 24 weeks
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.
5 secondary outcomes
Change in Eating Patterns and Behaviours
Time frame: Baseline, 8 weeks, and 24 weeks
Change in cardiovascular health
Time frame: Baseline, 8 weeks, and 24 weeks
Change in body composition
Time frame: Baseline, 8 weeks, and 24 weeks
Change in physical function
Time frame: Baseline, 8 weeks, and 24 weeks
Change in aerobic fitness
Time frame: Baseline, 8 weeks, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications arising from this study may be made available to qualified researchers upon reasonable request and following appropriate ethical and institutional approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shivangi Sharma, BSc contact
Julia Totosy de Zepetnek, PhD principal investigator
Univeristy of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise Program in people with Type 2 Diabetes Mellitus, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia O. Totosy de Zepetnek, PhD (306-585.4370, camerolabs@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin resistance (HOMA-IR) (time frame: Baseline, 8 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.