Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating a diagnostic algorithm for sarcopenic obesity

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

Run by University of Roma La Sapienza · NCT06815978 · Data updated 2026-11-12

This study is testing a new way to diagnose sarcopenic obesity, which is when someone has a lot of body fat but not enough muscle, by comparing it with regular obesity in 150 participants.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Rome, RM)
StatusRecruiting
StartedMay 24, 2024
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedFebruary 10, 2025
Trial IDNCT06815978 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are Caucasian individuals with a BMI of 30 or more who exhibit signs of sarcopenic obesity.

Probably not a fit

Patients with diseases or conditions that significantly affect body composition, such as malignant diseases or autoimmune disorders, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research project investigates sarcopenic obesity, a condition marked by high body fat and low muscle mass, focusing on muscle function. It aims to validate the ESPEN-EASO algorithm for diagnosing this condition by enrolling 75 subjects with sarcopenic obesity and a control group of 75 with non-sarcopenic obesity. The study will examine the consistency of diagnostic criteria in relation to biomarkers and functional outcomes, while also assessing additional variables through questionnaires and tests. Ethical standards will be upheld through informed consent and privacy protection.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of diagnosing sarcopenic obesity, leading to better-targeted treatments for affected patients.

How similar studies have gone: While there have been studies on sarcopenic obesity, the specific validation of the ESPEN-EASO algorithm in this context is a novel approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Azienda Policlinico Umberto I
    Rome, Rm, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.