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

ConditionType 2 Diabetes

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKristin Clemens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Are pregnant or breastfeeding

Are unable to perform functional tests

Are unable to provide informed consent

Have any contraindication to PET/CT scan

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants

are grouped into 1 trial group

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

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Change from baseline to 12 months

Secondary outcomes

Change in skeletal muscle quality at 3 and 6 months

Changes L3 skeletal muscle radiodensity 3 months and 6 months after initiation of semaglutide or tirzepatide. Measured at L3 lumbar vertebrae with PET-CT, in Hounsfield Units (HU).

Time frame

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

Change in skeletal muscle quality at 3 and 6 months

Changes L3 skeletal muscle radiodensity at 3 months and 6 months after initiation of semaglutide or tirzepatide. Measured at L3 lumbar vertebrae with PET-CT, in Hounsfield Units (HU).

Time frame

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 in muscle strength and function 3 months and 6 months 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.

Time frame

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

Change in Gait Speed at 3 and 6 months

Change in muscle strength and function 3 months and 6 months after starting semaglutide or tirzepatide. Usual-pace walking speed measured across a 4-meter course with a static start. Measured in meters per second.

Time frame

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

Other outcomes

Blood Flow in Muscle, Bone and Kidney

Changes in blood flow in muscle, bone and kidney 1 year after starting semaglutide or tirzepatide.

Time frame

12 months

Glucose Metabolism in Muscle, Bone and Kidney

Changes in glucose metabolism in muscle, bone and kidney 1 year after initiating semaglutide or tirzepatide.

Time frame

12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kristin Clemens

Lead sponsor

Western University, Canada

Sponsor institution

Source ClinicalTrials.gov

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