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Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Recruitingn/aAges 18 Years - anyAllElisa Giannetta
NCT06815978 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The proposed research project aims to investigate sarcopenic obesity (SO), a condition characterized by the combination of high body fat and low skeletal muscle mass, with a focus on muscle function. SO has been defined according to the ESPEN-EASO algorithm, and this study aims to evaluate its validity, exploring associations with circulating biomarkers and functional outcomes. By enrolling 75 subjects with SO and a control sample of 75 subjects with non-sarcopenic obesity, the primary objective of this study is to examine the consistency of the proposed diagnostic criteria with respect to circulating biomarkers and functional outcomes. Secondary objectives include the assessment of additional variables and the detailed profiling of SO subjects through questionnaires and multidimensional tests. The ethical aspect of the present study will be guaranteed through written informed consent an

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📋 Eligibility rules (as published)
Inclusion Criteria: * BMI equal more than 30 * Caucasians Exclusion Criteria: * any disease or medication that can significantly affect body composition (eg.malignant diseases in the last 5 years, autoimmune diseases, neurological diseases, syndromic obesity), * level of physical activity more than 3 METS * alcohol intake more than 140g/wk for M and 70g/wk for F * participation in a weight-reducing program (last 3 months), * impossibility to perform DXA exam * pregnancy and breast-feeding.
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What it tests

  • DXA
  • ultrasonography
  • indirect calorimetry
  • MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
  • bioimpedentiometry
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Where

1 site
Azienda Policlinico Umberto I
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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