Imaging in Semaglutide Study

NCT07695454 | Not Yet Recruiting

• 1 other identifier: 25-823
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; BMI Greater Than 30

Outcome Measures

Primary Outcomes (8)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• Effects of semaglutide therapy on patients muscle composition 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.

  6 months

• Effects of semaglutide therapy on patients muscle composition measured by MR water-fat imaging.

  6 months

• Effects of semaglutide therapy on patients muscle fatty infiltration measured by MR water-fat imaging.

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

  6 months

• 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 muscle strength.

  6 months

Interventions

31P-MRS and MRI RADIATION

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

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients screened in the medical health record

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Andrea Parianos

CONTACT

216-445-8354; debsa@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: July 10, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)