Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElisa Giannetta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI equal more than 30

Caucasians

Disqualifiers

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),

Trial population

clinical setting from Azienda Policlinico Umberto I, Rome, Italy

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • DXA

    Diagnostic test

    Dual energy X-ray absorptiometry

  • ultrasonography

    Diagnostic test

    ultrasonography

  • indirect calorimetry

    Diagnostic test

    indirect calorimetry

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

    Diagnostic test

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

  • bioimpedentiometry

    Diagnostic test

    bioimpedentiometry

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Patient with sarcopenic obesity5 interventions
Group B: Patients with obesity5 interventions

Trial outcomes

Primary outcomes

1

Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis

Time frame
baseline, 6 month
2

Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis

Time frame
baseline, 6 month
3

Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis

Time frame
baseline, 6 month
4

Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis

Time frame
baseline, 6 month

Secondary outcomes

1

Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis

Time frame
baseline, 6 month
2

Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by DXA) in Odd Ratios as assessed by multivariate analysis

Time frame
baseline, 6 month
3

Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by BIA) in Odd Ratios as assessed by multivariate analysis

Time frame
baseline, 6 month
4

Association between diagnostic criteria for Sarcopenic Obesity and skeletal muscle mass (assessed by BIA) in Odd Ratios as assessed by multivariate analysis

Time frame
baseline, 6 month

Other outcomes

1

weight in Kilograms

Time frame
on enrollment day and at the end of the intervention (6 month)
2

Height in meters

Time frame
on enrollment day and at the end of the intervention (6 month)
3

calf circumference in centimeters

Time frame
on enrollment day and at the end of the intervention (6 month)
4

mid-arm muscle circumference in centimeters

Time frame
on enrollment day and at the end of the intervention (6 month)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elisa Giannetta

Lead sponsor

University of Roma La Sapienza

Sponsor institution

ministero della ricerca e dell'università

Collaborator