Actively Recruiting

Age: 18Years +
All Genders
NCT06815978

Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Led by Elisa Giannetta · Updated on 2025-02-10

150

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

E

Elisa Giannetta

Lead Sponsor

M

ministero della ricerca e dell'università

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI equal or more than 30
  • Caucasian ethnicity
Not Eligible

You will not qualify if you...

  • Any disease or medication that significantly affects body composition, including malignant diseases in the last 5 years, autoimmune diseases, neurological diseases, or syndromic obesity
  • Physical activity level over 3 METS
  • Alcohol intake over 140g/week for men and 70g/week for women
  • Participation in a weight-reducing program in the last 3 months
  • Inability to perform DXA exam
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda Policlinico Umberto I

Rome, RM, Italy, 00161

Actively Recruiting

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Research Team

E

Elisa Giannetta

CONTACT

L

Lorenzo M Donini

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity | DecenTrialz