Evaluating a diagnostic algorithm for sarcopenic obesity
Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity (SO)
University of Roma La Sapienza · NCT06815978
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 type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Roma La Sapienza (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06815978 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Caucasian individuals with a BMI of 30 or more who exhibit signs of sarcopenic obesity.
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.
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 performed: While there have been studies on sarcopenic obesity, the specific validation of the ESPEN-EASO algorithm in this context is a novel approach.
Eligibility criteria
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 this trial is running
Rome, RM
- Azienda Policlinico Umberto I — Rome, RM, Italy (RECRUITING)
Study contacts
- Study coordinator: Elisa Giannetta
- Email: elisa.giannetta@uniroma1.it
- Phone: 0039-0649970711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sarcopenic Obesity, Sarcopenic obesity, obesity, nutrition, gut microbiome, diagnostic ciriteria