Actively Recruiting
Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity
Led by Elisa Giannetta · Updated on 2025-02-10
150
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating sarcopenic obesity (SO), a condition that combines high body fat with low muscle mass, focusing on how it affects muscle function. This study evaluates the ESPEN-EASO algorithm used to diagnose SO by examining its relationship with blood biomarkers and physical abilities. The study aims to improve understanding and validation of SO diagnosis through detailed testing and questionnaires involving adults with and without SO. The study involves enrolling 75 adults with sarcopenic obesity and 75 adults with obesity but without sarcopenia as a control group. Participants will undergo diagnostic tests including dual energy X-ray absorptiometry (DXA), ultrasonography, indirect calorimetry, magnetic resonance imaging/spectroscopy (MRI/MRS), and bioimpedentiometry. These tests help measure body composition, muscle mass, and fat distribution, alongside evaluating muscle function and circulating biomarkers. Participants will be assessed at the start and after 6 months to examine associations between diagnostic criteria and various blood markers such as liver enzymes, cholesterol, hormones, inflammatory markers, and muscle strength tests like hand-grip and walking tests. The study also includes questionnaires and multidimensional tests to profile participants more thoroughly. Privacy protections and informed consent are ensured, and the total observation period includes baseline and 6-month follow-up evaluations.
CONDITIONS
Brief Title
Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI equal to or greater than 30
- Caucasian ethnicity
- Age 18 years or older
You will not qualify if you...
- Any disease or medication significantly affecting body composition, such as malignant diseases in the last 5 years, autoimmune diseases, neurological diseases, or syndromic obesity
- Physical activity level greater than 3 METS
- Alcohol intake exceeding 140g per week for males and 70g per week for females
- Participation in a weight-reducing program within 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and 6 months
Participants undergo diagnostic tests including DXA, ultrasonography, indirect calorimetry, MRI/MRS, and bioimpedentiometry to assess body composition and related health indicators.
2 visits (in-person)
Duration - 6 months
Participants are monitored over 6 months to assess associations between diagnostic criteria for Sarcopenic Obesity and various health markers.
Follow-up assessments at 6 months
Trial Site Locations
Total: 1 location
1
Azienda Policlinico Umberto I
Rome, RM, Italy, 00161
Actively Recruiting
Research Team
E
Elisa Giannetta
L
Lorenzo M Donini
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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