Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Elisa Giannetta

Status

Enrolling

Conditions

Sarcopenic Obesity

Treatments

Diagnostic Test: ultrasonography

Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Diagnostic Test: DXA

Diagnostic Test: indirect calorimetry

Diagnostic Test: bioimpedentiometry

Study type

Observational

Funder types

Other

Identifiers

NCT06815978

PRIN-202229ET3S

Details and patient eligibility

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.