Current partner codePEPTIDESDE
NCT07695454·Not applicable·OBSERVATIONAL

Imaging in Semaglutide Study

Status

Not yet recruiting

Phase

Not applicable

Enrollment

10

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

Type 2 diabetes (T2D),characterized by insulin resistance and abnormal metabolic functions, is the most prevalent metabolic syndrome disease (1). Excess weight gain is the number one risk factor for development of T2D, in which 85% of individuals with T2D are either overweight or obese (2). While weight management through diet and exercise is foundational for treatment, genetic and environmental factors pose challenges (3). Recently, once-weekly subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), and tirzepatide, a gastric inhibitory peptide/glucagon-like peptide-1 dual receptor agonist (GIP/GLP-1RA), were approved for the treatment of T2D as well as obesity (4, 5). They have displayed significant efficacy in improving glycemic control and weight reduction in both individuals with overweight or obesity with or without T2D (6). However, the significant weight loss associated with these medications is not only related to reduction in body fat mass, but also loss of body lean mass, as observed in previous clinical studies (7). Indeed, this raises concern in older individuals for the development of sarcopenic obesity, a medical condition defined by the presence of both sarcopenia (loss of muscle) and obesity, a condition associated with poor morbidity and mortality (7, 8). However, it remains unclear whether the substantial reduction in body fat and lean mass is directly associated with changes in skeletal muscle volume, strength, quality and metabolic function. This proposal aims to address this gap by evaluating the longitudinal effect of semaglutide treatment on skeletal muscle metabolic function in individuals with T2D and obesity. The study will evaluate skeletal muscle strength of the patients of T2D and obesity undergoing semaglutide therapy and leverage MRI and phosphorus-31 magnetic resonance spectroscopy (31P-MRS) to assess changes in skeletal muscle volume, quality and metabolic functions pertaining to muscle mitochondria.

Interventions

Treatment arms and agents.

RADIATION

31P-MRS and MRI

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

Timeline

From registration to results.

  1. First posted

    Jul 10, 2026

  2. Study start

    Jul 15, 2026

  3. Primary completion

    Dec 30, 2026

  4. Study completion

    Jun 1, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 10, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Gender: men and women 2. Ethnicity: all ethnic groups 3. Age between 45 and 75 years 4. BMI ≥ 30 kg/m2 and BMI \< 45 kg/m2 5. Diagnosis of Type 2 Diabetes (T2D) with HbA1c levels between 7% and 10.5%. 6. Starting subcutaneous semaglutide for clinically indicated T2D management. 7. Ability and willingness to participate in the study for its full duration. 8. Provision of informed consent for participation in research. Exclusion Criteria: 1. Previous intolerance or allergy to any semaglutide-based therapy. 2. History of prior intolerance to any GLP-1RA or GIP/GLP-1RA. 3. Unwillingness or uncertainty to commit to the duration of the study. 4. 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). 5. History of myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass) within 30 days prior to screening. 6. History of hospitalization for heart failure within the past 30 days, or NYHA class IV 7. Current use of glucocorticoid therapy (≥5 mg prednisone or equivalent). 8. Self-reported weight loss \> 10 lbs in the 90 days prior to screening. 9. Use of other mediation, on or off-label, for the primary intent of weight loss within 90 days prior to screening. 10. Secondary etiologies for sarcopenia (e.g., gastrointestinal malabsorption, myopathies, severe neurological conditions). 11. Glomerular Filtration Rate (eGFR) within the past 120 days is not available. 12. Mental incapacity or language barriers preventing informed consent and compliance. 13. Pregnancy, plans for pregnancy in the next 12 months, or lactating/nursing females. 14. History of bariatric or metabolic surgery or related procedures. 15. Prior participation in the Endocrinology and Metabolism Institute's Integrated Weight Management Program within the past 3 months. 16. Active smoking. 17. Excessive alcohol consumption, defined as ≥3 drinks per day. 18. Uncontrolled lung disease (e.g., severe asthma or COPD). 19. Uncontrolled thyroid disease. 20. Personal commitments that may limit optimal participation (e.g., work, travel, caregiving responsibilities). 21. History of malabsorptive disorders, such as celiac disease or Crohn's disease. 22. Cholestatic liver disease or inadequate hepatic function (AST/ALT \> 3.0 x ULN). 23. Liver cirrhosis. 24. Conductive implanted devices (e.g., cardiac pacemaker, cardioverter-defibrillators). 25. Major surgical procedures or significant traumatic injury within 30 days prior to the enrollment date. 26. 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). 27. Any condition, unwillingness, or inability, not otherwise covered by exclusion criteria, which might jeopardize the subject's safety or compliance with the protocol. 28. Presence of metal in the eye

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Cleveland Clinic

Cleveland, Ohio, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.