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Imaging in Semaglutide Study

31P-MRS and MRI Imaging in Semaglutide Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows adults with type 2 diabetes and obesity who are starting semaglutide. It uses muscle strength tests and special MRI scans to track changes in muscle size, quality, and energy use. Visits take place at the start, at 3 months, and at 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women from all ethnic groups may join.
  • You are 45 to 75 years old.
  • Your BMI is at least 30 but below 45. BMI is a measure of weight compared with height.
  • You have type 2 diabetes and an HbA1c of 7% to 10.5%. This blood test measures average blood sugar.
  • You are starting semaglutide shots under the skin to treat type 2 diabetes.
  • You can and will take part for the full study.
  • You understand the study and agree to take part.

Who can't join

  • You have had an allergy to semaglutide or could not tolerate it or related drugs called GLP-1 or GIP/GLP-1 drugs.
  • You cannot safely have an MRI, have metal in your eye or certain implanted devices, or fear tight spaces. Your largest calf measures more than 17 inches (43 cm) around.
  • You had a heart attack, a procedure to restore blood flow to the heart, major surgery, or a serious injury in the past 30 days. A recent heart failure hospital stay or the most severe class of heart failure also rules you out.
  • You take steroid medicine equal to at least 5 mg of prednisone, lost more than 10 pounds in the past 90 days, or used medicine mainly for weight loss in that time.
  • You have had weight-loss surgery or related procedures, or joined the institute's Integrated Weight Management Program in the past 3 months.
  • You are pregnant, plan pregnancy in the next 12 months, or are breastfeeding. You currently smoke or drink at least 3 alcoholic drinks a day.
  • You have certain muscle, nerve, food-absorption, liver, uncontrolled lung, or uncontrolled thyroid problems. You also need an available kidney-filtering test result from the past 120 days.
  • You cannot give informed consent or commit to study visits and rules. The study doctor may also rule you out for other health or safety concerns.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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