NCT06815978Recruiting
Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity
Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity (SO)
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 24 May 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Elisa Giannetta
- Diseases
- Obesity
- NCT number
- NCT06815978
What you commit to
- Study type: Observational
- Planned participants: 150
- From 24 May 2024 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- any disease or medication that can significantly affect body composition (eg.malignant diseases in the last 5 years, autoimmune diseases, neurological diseases, syndromic obesity),
Other
- 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.
Who the study is looking for
- BMI equal more than 30
- Caucasians
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.