About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI equal more than 30
Caucasians
Disqualifiers
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),
Trial population
clinical setting from Azienda Policlinico Umberto I, Rome, Italy
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
DXA
Diagnostic testDual energy X-ray absorptiometry
ultrasonography
Diagnostic testultrasonography
indirect calorimetry
Diagnostic testindirect calorimetry
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Diagnostic testMRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
bioimpedentiometry
Diagnostic testbioimpedentiometry
Treatment groups
Trial outcomes
Primary outcomes
Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis
Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis
Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis
Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis
Secondary outcomes
Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis
Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by DXA) in Odd Ratios as assessed by multivariate analysis
Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by BIA) in Odd Ratios as assessed by multivariate analysis
Association between diagnostic criteria for Sarcopenic Obesity and skeletal muscle mass (assessed by BIA) in Odd Ratios as assessed by multivariate analysis
Other outcomes
weight in Kilograms
Height in meters
calf circumference in centimeters
mid-arm muscle circumference in centimeters
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Elisa Giannetta
Lead sponsor
University of Roma La Sapienza
Sponsor institution
ministero della ricerca e dell'università
Collaborator