Type 2 DiabetesNCT07695454
Imaging in Semaglutide Study
An observational study of Type 2 Diabetes and BMI Greater Than 30, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes, BMI Greater Than 30
- What is being tested?
- 31P-MRS and MRI
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients screened in the medical health record
Who may be able to join
- 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.
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Andrea Parianos, 216-445-8354, debsa@ccf.org
About this study
Official title: 31P-MRS and MRI Imaging in Semaglutide Study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, BMI Greater Than 30
- Being tested
- 31P-MRS and MRI
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31P-MRS and MRIRadiation
31P-MRS and MRI for patients with Type 2 Diabetes and obesity prescribed to semaglutide therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Effects of semaglutide therapy on patients muscle composition measured by MR water-fat imaging.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Jul 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695454
- Sponsor's protocol ID
- 25-823
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 31P-MRS and MRI Imaging in Semaglutide Study
- ClinicalTrials.gov ID
- NCT07695454
- Acronym / sponsor ID
- 25-823
- Conditions
- Type 2 Diabetes, BMI Greater Than 30
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients screened in the medical health record
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 31P-MRS and MRI31P-MRS and MRI for patients with Type 2 Diabetes and obesity prescribed to semaglutide therapy | Radiation | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and BMI Greater Than 30, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Parianos (216-445-8354, debsa@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of semaglutide therapy on patients muscle mitochondrial function as quantified using phosphorous MR spectroscopy. (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.