Incretin Therapy and Exercise in Type 2 Diabetes

Study acronym: BIOM
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
5,101 trials monitored
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2,236 trials monitored
See 113 trials at risk
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.
Trial Details
NCT Number NCT07833813
Lead Sponsor University of Regina
Conditions
(from sponsor)
Type 2 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 2, Motor Activity
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov