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NCT07156331Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
7 Aug 2025
Start date
1 Oct 2025
Primary completion date
1 Oct 2027
Lead sponsor
Kristin Clemens
NCT number
NCT07156331

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 1 Oct 2025 to the primary completion date, 1 Oct 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Are pregnant or breastfeeding
  • Are unable to perform functional tests
  • Are unable to provide informed consent
  • Have any contraindication to PET/CT scan

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.