No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Any
Study type
Observational
Participants needed
10 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for adults aged 45 to 75 who are prescribed semaglutide for type 2 diabetes and have a body mass index (BMI) of 30 or greater. Participants will be monitored at different points over six months to see how their muscle health changes with the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 45 and 75 years old.
I have a BMI of 30 or more.
I have been diagnosed with type 2 diabetes.
My HbA1c levels are between 7% and 10.5%.
I am starting semaglutide for my diabetes treatment.
I can commit to the study for its full duration.
I can provide informed consent for research.
You may not be able to join if
I have had an allergy to semaglutide before.
I have had heart issues in the last month.
I am pregnant or planning to get pregnant in the next year.
I am currently smoking or drinking excessively.
I have had major surgery or injury in the last month.
I have certain medical conditions that would make me unfit for the trial.
I have metal in my eye.
I cannot commit to the study duration.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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)…
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.
Trial Locations
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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 managemen…
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
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