Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- BMI equal or more than 30
- Caucasian ethnicity
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
Trial Site Locations
Total: 1 location
1
Azienda Policlinico Umberto I
Rome, RM, Italy, 00161
Actively Recruiting
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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