Imaging in Semaglutide Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-75
SponsorThe Cleveland Clinic
About this trial
In this preliminary observation study, the investigators will assess muscle function in terms of muscle strength and leverage imaging (MRI) and spectroscopy (31P-MRS) based techniques to assess longitudinal changes in muscle volume, quality and metabolic function in patients with T2D and obesity prescribed to semaglutide therapy. The patients will be evaluated at three time points: 1) baseline, 2) 3-month and 3) 6-month after the therapy. These longitudinal changes will then be compared and correlated with changes in physical measurements such as BMI and patient reported outcome measures (PROMs). The primary aim of our study is to investigate the longitudinal effects of semaglutide therapy on patients with T2D and obesity, on skeletal muscle strength, muscle volume, quality and metabolic function.
Eligibility criteria
Qualifiers
Gender: men and women
Ethnicity: all ethnic groups
Age between 45 and 75 years
BMI ≥ 30 kg/m2 and BMI < 45 kg/m2
Disqualifiers
Previous intolerance or allergy to any semaglutide-based therapy.
History of prior intolerance to any GLP-1RA or GIP/GLP-1RA.
Unwillingness or uncertainty to commit to the duration of the study.
Contraindication to MRI (e.g. claustrophobia, implanted devices including cardiac pacemaker and cardioverter-defibrillators), circumference of largest calf > 17inch/43cm (max size to fit into the MR coil).
Trial design
Treatments tested in this trial
- 31P-MRS and MRI
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov