Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

NCT ID: NCT06815978

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-24

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenic Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient with sarcopenic obesity

DXA

Intervention Type DIAGNOSTIC_TEST

Dual energy X-ray absorptiometry

ultrasonography

Intervention Type DIAGNOSTIC_TEST

ultrasonography

indirect calorimetry

Intervention Type DIAGNOSTIC_TEST

indirect calorimetry

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Intervention Type DIAGNOSTIC_TEST

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

bioimpedentiometry

Intervention Type DIAGNOSTIC_TEST

bioimpedentiometry

Patients with obesity

DXA

Intervention Type DIAGNOSTIC_TEST

Dual energy X-ray absorptiometry

ultrasonography

Intervention Type DIAGNOSTIC_TEST

ultrasonography

indirect calorimetry

Intervention Type DIAGNOSTIC_TEST

indirect calorimetry

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Intervention Type DIAGNOSTIC_TEST

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

bioimpedentiometry

Intervention Type DIAGNOSTIC_TEST

bioimpedentiometry

Interventions

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DXA

Dual energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

ultrasonography

ultrasonography

Intervention Type DIAGNOSTIC_TEST

indirect calorimetry

indirect calorimetry

Intervention Type DIAGNOSTIC_TEST

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Intervention Type DIAGNOSTIC_TEST

bioimpedentiometry

bioimpedentiometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ministero della ricerca e dell'università

UNKNOWN

Sponsor Role collaborator

Elisa Giannetta

OTHER

Sponsor Role lead

Responsible Party

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Elisa Giannetta

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Azienda Policlinico Umberto I

Rome, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elisa Giannetta

Role: CONTACT

0039-0649970711

Lorenzo M Donini

Role: CONTACT

0039-0649910162

Facility Contacts

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Donini

Role: primary

0039-0649910162

Other Identifiers

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PRIN-202229ET3S

Identifier Type: -

Identifier Source: org_study_id

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