A Prospective Observational Study to Evaluate Changes in Body Composition and Physical Function Using Imaging in Participants With Type 2 Diabetes Initiating GLP-1 Receptor Agonist Therapy (REBUILD)

NCT07156331Sponsor: Kristin ClemensKKristin Clemens

Actively Recruiting

The Metabolic and Chronic Disease Research Unit

Research Team

View on ClinicalTrials.gov ↗

About This Study

This prospective, single-arm study evaluates the impact of GLP-1RA or GLP-1RA/GIP agonists on muscle and bone health in 20 patients with type 2 diabetes. Investigators utilize advanced PET/CT imaging at baseline, 3, 6, and 12 months to quantify changes in intramuscular fat, bone blood flow, and glucose metabolism following medication initiation. The study also tracks longitudinal changes in physical function through grip strength, gait speed, and Timed Up and Go assessments. The primary objective is to characterize early markers of sarcopenia and bone fragility to assist in the development of clinical prediction tools for patients at high risk of frailty. Findings aim to guide the integration of bone-protecting therapies or physical therapy for patients prescribed semaglutide or tirzepatide.

Who Can Participate?

Inclusion Criteria

  • Be at least 18 years old
  • Have type 2 diabetes
  • Have recently been started on semaglutide or tirzapatide under the care of a physician
  • Be able to speak and read English

Exclusion Criteria

  • Are pregnant or breastfeeding
  • Are unable to perform functional tests
  • Are unable to provide informed consent
  • Have any contraindication to PET/CT scan
  • Had a change in body weight over 5 kilograms within 90 days before starting a GLP-1RA or GLP-1RA/GIP
  • Had previous or planned (during the study period) bariatric surgery in the subsequent 12 months.
Study website ↗