Research on Effects of Drugs on Body Composition and Function With Imaging in Diabetes

What this study is testing ClinicalTrials.gov NCT07156331 ↗

Description as written by the study sponsor.

One downside of diabetes weight loss drugs like GLP-1RA and GLP-1RA/GIP, is that they can cause muscle loss, which is especially risky for older adults or those already prone to frailty and falls. There is also concern that GLP-1RA might affect bone health, possibly leading to weaker bones and increased risk of fractures. To prevent these issues, doctors need to better predict who is most at risk of muscle and/or bone loss. That way, doctors can adjust patient management-like adding targeted physical therapy, or bone-protecting medications alongside GLP-1RA or GLP-1RA/GIP medications. Medical imaging can help spot early muscle and bone changes. Advanced imaging, like PET and CT scans allow for the assessment of muscle fat content and blood flow in the bones and muscles. This could provide clearer insights into how GLP-1RA or GLP-1RA/GIP medications affect muscles and bones in ways that matter for patients (strength, mobility, falls risk, etc.). The investigators will conduct an exploratory study of 20 patients initiating on GLP-1RA or GLP-1RA/GIP by their care provider, and assess their muscle and bone health at baseline, 3, 6, and 12 months using advanced PET/CT imaging. The investigators will also assess functional measures, including grip strength, Timed Up and Go test, and gait speed. The goal is to measure and describe early changes in body composition and physical function that could signal harm. These findings will help to develop a clinical prediction tool for clinicians to use prior to starting semaglutide or tirzepatide, as well as design interventions to help promote healthy muscle and bone while on treatment.