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

NCT07156331 | Not Yet Recruiting

• 1 other identifier: REBUILD
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

T2DM; Type 2 Diabetes; Semaglutide; Tirzepatide; GLP-1RA; GLP-1RA/GIP; Body Mass; Muscle Composition; Muscle Mass; Mounjaro; Ozempic; Wegovy; DM2; Diabetes Mellitus 2; Muscle Strength; Muscle Function; Muscle Preservation; Bone Health

Outcome Measures

Primary Outcomes (4)

• Change in skeletal muscle mass at 1-year

  Changes in skeletal muscle mass 1-year after initiation semaglutide or tirzepatide. Measured at the L3 lumbar vertebrae with PET-CT, in cm²/m².

  Change from baseline to 12 months

• Change in Timed Up-and-Go (TUG) at 1-year

  Change in muscle strength and function 1-year after starting semaglutide or tirzepatide. Measures the time in seconds to stand from a standard chair, walk 3 meters, turn, walk back and sit down. Measured in seconds.

  Change from baseline to 12 months

• Change in Gait Speed at 1-year

  Change in muscle strength and function 1-year after starting semaglutide or tirzepatide. Usual-pace walking speed measured across a 4-meter course with a static start. Measured in meters per second.

  Change from baseline to 12 months

• Change in Handgrip Strength at 1-year

  Change in muscle strength - handgrip strength change 1-year after starting semaglutide or tizepatide. Measured using handheld dynamometer in the dominant hand, in kg.

  Change from baseline to 12 months

Secondary Outcomes (5)

• Change in skeletal muscle quality at 3 and 6 months

  Change from baseline to 3 months, change from baseline to 6 months

• Change in skeletal muscle quality at 3 and 6 months

  Change from baseline to 3 months, change from baseline to 6 months

• Change in Timed Up-and-Go (TUG) at 3 and 6 months

  Change from baseline to 3 months, change from baseline to 6 months

• Change in Gait Speed at 3 and 6 months

  Change from baseline to 3 months, change from baseline to 6 months

• Change in Handgrip Strength at 3 and 6 months

  Change from baseline to 3 months, change from baseline to 6 months

Other Outcomes (2)

• Blood Flow in Muscle, Bone and Kidney

  12 months

• Glucose Metabolism in Muscle, Bone and Kidney

  12 months

Study Arms (1)

Adults with T2DM that have recently been started on GLP-1RA or GLP-1RA/GIP Medication

Adults at least 18 years of age that have Type 2 Diabetes, have recently been started on semaglutide or tirzepatide under the care of a physician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 or older with type 2 diabetes that have recently been started on semaglutide or tirzepatide under the care of a physician.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kristin Clemens: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kristin Clemens, MD, MSc

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather LaPier, BSc

CONTACT

519-646-6100; heather.lapier@sjhc.london.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share