Incretin Therapy + Exercise for Diabetes
(BIOM Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Julia Totosy de Zepetnek, PhD
Principal Investigator
Univeristy of Regina
Are You a Good Fit for This Trial?
This trial is for adults with type 2 diabetes who are starting incretin-mimetic medications like Ozempic or Mounjaro. Participants should be able to safely take these medicines and join an exercise program, as determined by the study team.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two groups: one receives only incretin-mimetic therapy, while the other gets both this medication and a structured exercise program over 24 weeks. The goal is to see if adding exercise improves brain and physical health more than medication alone.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Regina
Lead Sponsor
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