NCT07695454Toboroz
Imaging in Semaglutide Study
31P-MRS and MRI Imaging in Semaglutide Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 6.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 10 (tervezett)
- Első benyújtás
- 2026. máj. 8.
- Kezdés
- 2026. júl. 30.
- Elsődleges befejezés
- 2026. dec. 30.
- Fő szponzor
- The Cleveland Clinic
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07695454
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 10
- 2026. júl. 30. és az elsődleges befejezés (2026. dec. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Previous intolerance or allergy to any semaglutide-based therapy.
- History of prior intolerance to any GLP-1RA or GIP/GLP-1RA.
- History of myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass) within 30 days prior to screening.
- 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.
- Prior participation in the Endocrinology and Metabolism Institute's Integrated Weight Management Program within the past 3 months.
- Major surgical procedures or significant traumatic injury within 30 days prior to the enrollment date.
Más betegség
- 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 hospitalization for heart failure within the past 30 days, or NYHA class IV
- Secondary etiologies for sarcopenia (e.g., gastrointestinal malabsorption, myopathies, severe neurological conditions).
- History of bariatric or metabolic surgery or related procedures.
- Uncontrolled lung disease (e.g., severe asthma or COPD).
- Uncontrolled thyroid disease.
- History of malabsorptive disorders, such as celiac disease or Crohn's disease.
- Conductive implanted devices (e.g., cardiac pacemaker, cardioverter-defibrillators).
- 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.
Laborértékek
- Glomerular Filtration Rate (eGFR) within the past 120 days is not available.
- Cholestatic liver disease or inadequate hepatic function (AST/ALT > 3.0 x ULN).
Egyéb
- Unwillingness or uncertainty to commit to the duration of the study.
- Mental incapacity or language barriers preventing informed consent and compliance.
- Pregnancy, plans for pregnancy in the next 12 months, or lactating/nursing females.
- Active smoking.
- Excessive alcohol consumption, defined as ≥3 drinks per day.
- Personal commitments that may limit optimal participation (e.g., work, travel, caregiving responsibilities).
- Liver cirrhosis.
- Presence of metal in the eye
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 45 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Cleveland Clinic | Cleveland | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.