NCT07695454 · The Cleveland Clinic
Imaging in Semaglutide Study
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
31P-MRS and MRI
31P-MRS and MRI for patients with Type 2 Diabetes and obesity prescribed to semaglutide therapy
Primary outcome measures
Effects of semaglutide therapy on patients muscle mitochondrial function as quantified using phosphorous MR spectroscopy.
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity on metabolic function.
Effects of semaglutide therapy on patients muscle fatty infiltration measured by MR relaxation time (T1, T2 and T1rho) mapping.
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity, on skeletal muscle quality.
Effects of semaglutide therapy on patients measured by hand grip.
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity on muscle strength.
Effects of semaglutide therapy on patients measured by MRI.
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity, on muscle volume.
Effects of semaglutide therapy on patients muscle composition measured by MR relaxation time (T1, T2 and T1rho) mapping.
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity, on skeletal muscle quality.
Effects of semaglutide therapy on patients muscle composition measured by MR water-fat imaging.
Time frame: 6 months
Effects of semaglutide therapy on patients muscle fatty infiltration measured by MR water-fat imaging.
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity, on skeletal muscle quality.
Effects of semaglutide therapy on patients muscle fatty infiltration measured by MR relaxation time (T1, T2 and T1rho) mapping
Time frame: 6 months
Longitudinal effects of semaglutide therapy on patients with Type 2 diabetes and obesity on muscle strength.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Gender: men and women
- Ethnicity: all ethnic groups
- Age between 45 and 75 years
- BMI ≥ 30 kg/m2 and BMI \< 45 kg/m2
- Diagnosis of Type 2 Diabetes (T2D) with HbA1c levels between 7% and 10.5%.
- Starting subcutaneous semaglutide for clinically indicated T2D management.
- Ability and willingness to participate in the study for its full duration.
- Provision of informed consent for participation in research.
Exclusion criteria
- 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).
- History of myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass) within 30 days prior to screening.
- History of hospitalization for heart failure within the past 30 days, or NYHA class IV
- Current use of glucocorticoid therapy (≥5 mg prednisone or equivalent).
- Self-reported weight loss \> 10 lbs in the 90 days prior to screening.
- Use of other mediation, on or off-label, for the primary intent of weight loss within 90 days prior to screening.
- Secondary etiologies for sarcopenia (e.g., gastrointestinal malabsorption, myopathies, severe neurological conditions).
- Glomerular Filtration Rate (eGFR) within the past 120 days is not available.
- Mental incapacity or language barriers preventing informed consent and compliance.
- Pregnancy, plans for pregnancy in the next 12 months, or lactating/nursing females.
- History of bariatric or metabolic surgery or related procedures.
- Prior participation in the Endocrinology and Metabolism Institute's Integrated Weight Management Program within the past 3 months.
- Active smoking.
- Excessive alcohol consumption, defined as ≥3 drinks per day.
- Uncontrolled lung disease (e.g., severe asthma or COPD).
- Uncontrolled thyroid disease.
- Personal commitments that may limit optimal participation (e.g., work, travel, caregiving responsibilities).
- History of malabsorptive disorders, such as celiac disease or Crohn's disease.
- Cholestatic liver disease or inadequate hepatic function (AST/ALT \> 3.0 x ULN).
- Liver cirrhosis.
- Conductive implanted devices (e.g., cardiac pacemaker, cardioverter-defibrillators).
- Major surgical procedures or significant traumatic injury within 30 days prior to the enrollment date.
- Any medical or surgical condition that, in the opinion of the principal investigator, may make the participant unfit for the trial (e.g., psychiatric disorders, malignancy).
- Any condition, unwillingness, or inability, not otherwise covered by exclusion criteria, which might jeopardize the subject's safety or compliance with the protocol.
- Presence of metal in the eye
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations