Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Official title

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

Overview

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.

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

Primary outcome measures

• Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and AST in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and ALT in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and GGT in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and alkaline phosphatase in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and total bilirubin in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and fractionated bilirubin in Odd Ratios as assessed by Multivariate analysis [Time frame: baseline, 6 month]

Secondary outcome measures (7)

• Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by DXA) in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by BIA) in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and skeletal muscle mass (assessed by BIA) in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and appendicular lean mass to weight in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and bone mineral density in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and visceral adipose tissue (assessed by DXA) in Odd Ratios as assessed by multivariate analysis [Time frame: baseline, 6 month]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

Italy · 1 center

• Azienda Policlinico Umberto I — Rome

Identifiers

NCT: NCT06815978 · PRIN-202229ET3S

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗