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RECRUITING
NCT06815978

Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Sponsor: Elisa Giannetta

View on ClinicalTrials.gov

Summary

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.

Official title: Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity (SO)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-05-24

Completion Date

2027-03-01

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

DXA

Dual energy X-ray absorptiometry

DIAGNOSTIC_TEST

ultrasonography

ultrasonography

DIAGNOSTIC_TEST

indirect calorimetry

indirect calorimetry

DIAGNOSTIC_TEST

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

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

DIAGNOSTIC_TEST

bioimpedentiometry

bioimpedentiometry

Locations (1)

Azienda Policlinico Umberto I

Rome, RM, Italy