Health TrialsbyHealthPanel

Imaging in Semaglutide Study

ConditionsType 2 DiabetesBMI Greater Than 30
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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 population

patients screened in the medical health record

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 31P-MRS and MRI

    Radiation

    31P-MRS and MRI for patients with Type 2 Diabetes and obesity prescribed to semaglutide therapy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Effects of semaglutide therapy on patients muscle mitochondrial function as quantified using phosphorous MR spectroscopy.

Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity on metabolic function.

Time frame
6 months
2

Effects of semaglutide therapy on patients muscle fatty infiltration measured by MR relaxation time (T1, T2 and T1rho) mapping.

Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity, on skeletal muscle quality.

Time frame
6 months
3

Effects of semaglutide therapy on patients measured by hand grip.

Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity on muscle strength.

Time frame
6 months
4

Effects of semaglutide therapy on patients measured by MRI.

Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity, on muscle volume.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov
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