TrialGlobe

Clinical trial

Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT06815978

Recruiting nowNot applicableObservational

What this study is about

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 and protection of privacy, respecting international regulatory standards. The investigators believe that this work provides significant contributions to the understanding of sarcopenic obesity and to the validation of diagnostic criteria, with possible implications for public health. The investigators are available for further clarifications and approvals required by the Ethics Committee.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionSarcopenic Obesity

Full registry criteria

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.

Treatments and study arms

DXA

Diagnostic Test

Dual energy X-ray absorptiometry

ultrasonography

Diagnostic Test

ultrasonography

indirect calorimetry

Diagnostic Test

indirect calorimetry

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Diagnostic Test

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

bioimpedentiometry

Diagnostic Test

bioimpedentiometry

Primary outcomes

Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and AST in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ALT in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GGT in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and alkaline phosphatase in Odd Ratios as assessed by Multivariate analysisbaseline, 6 month

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Azienda Policlinico Umberto I🇮🇹 Rome, RM, Italy
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DoniniContact
Email · Call 0039-0649910162