Sarcopenic ObesityNCT06815978
Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity
An observational study of Sarcopenic Obesity, run by Elisa Giannetta at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- DXA, ultrasonography and indirect calorimetry
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2024to 1 Mar 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinical setting from Azienda Policlinico Umberto I, Rome, Italy
Who may be able to join
- BMI equal more than 30
- Caucasians
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Policlinico Umberto I
Rome, RM, 00161
Donini, 0039-0649910162, lorenzomaria.donini@uniroma1.it
About this study
Official title: Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity (SO)
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
- Sarcopenic Obesity
- Being tested
- DXA, ultrasonography, indirect calorimetry, MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy), bioimpedentiometry
- Keywords
- Sarcopenic obesity, obesity, nutrition, gut microbiome, diagnostic ciriteria
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXADiagnostic test
Dual energy X-ray absorptiometry
ultrasonographyDiagnostic test
ultrasonography
indirect calorimetryDiagnostic test
indirect calorimetry
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)Diagnostic test
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
bioimpedentiometryDiagnostic test
bioimpedentiometry
| Study group | Role | What they receive |
|---|---|---|
| Patient with sarcopenic obesity | Not described Receives: Diagnostic Test: DXA; Diagnostic Test: ultrasonography; Diagnostic Test: indirect calorimetry; Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy); Diagnostic Test: bioimpedentiometry | |
| Patients with obesity | Not described Receives: Diagnostic Test: DXA; Diagnostic Test: ultrasonography; Diagnostic Test: indirect calorimetry; Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy); Diagnostic Test: bioimpedentiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and AST in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ALT in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GGT in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and alkaline phosphatase in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total bilirubin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and fractionated bilirubin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and triglyceride in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and free fatty acid (FFA) in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total cholesterol in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and HDL-Cholesterol in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and LDL-Cholesterol in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Apo A1 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Apo B in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and serum creatinine in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and blood urea nitrogen in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total proteins in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and albumin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and pseudocholinesterase in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and vitamin D3 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Vitamin B12 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Vitamin B6 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Hs-CRP in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Atrial Natriuretic Peptide (ANP) in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Brain Natriuretic Peptide in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and standard OGTT glycaemia in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and standard OGTT insulin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and C-peptide in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and TSH in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and FT3 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and FT4 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GH in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and IGF-1 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and acylated ghrelin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and unacylated ghrelin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and testosterone (in men) in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and estradiol (in women) in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and adrenal-derived dehydroepiandrosterone in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and myostatin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and leptin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and adiponectin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Irisin in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and parathormone in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and cortisol in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and sodium in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and potassium in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and calcium in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and phosphorus in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and chloride in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and magnesium in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and TNF-α in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 6 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 8 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 10 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 15 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 18 in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and hand-grip strength test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 5- time sit-to-stand test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and balance test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Gait speed 4m in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 6-minute walk test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Knee extension strenght in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Sit and reach test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Time up and go test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and One-Leg Standing balance in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 30s chair stand test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Joint mobility test in Odd Ratios as assessed by Multivariate analysis
Measured: baseline, 6 month
Secondary outcomes (7)
Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by DXA) in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by BIA) in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and skeletal muscle mass (assessed by BIA) in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and appendicular lean mass to weight in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and bone mineral density in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and visceral adipose tissue (assessed by DXA) in Odd Ratios as assessed by multivariate analysis
Measured: baseline, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start24 May 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Elisa Giannetta
- Sponsor type
- University, hospital or other
- Collaborators
- ministero della ricerca e dell'università
- Responsible party
- Sponsor-investigator, Elisa Giannetta, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815978
- Sponsor's protocol ID
- PRIN-202229ET3S
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity (SO)
- ClinicalTrials.gov ID
- NCT06815978
- Acronym / sponsor ID
- PRIN-202229ET3S
- Conditions
- Sarcopenic Obesity
- Keywords
- Sarcopenic obesity, obesity, nutrition, gut microbiome, diagnostic ciriteria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Elisa GiannettaUniversity, hospital or other
- Collaborators
- ministero della ricerca e dell'università
- Study start
- 24 May 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with sarcopenic obesity | – | Diagnostic Test: DXA, Diagnostic Test: ultrasonography, Diagnostic Test: indirect calorimetry, Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy), Diagnostic Test: bioimpedentiometry |
| Patients with obesity | – | Diagnostic Test: DXA, Diagnostic Test: ultrasonography, Diagnostic Test: indirect calorimetry, Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy), Diagnostic Test: bioimpedentiometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinical setting from Azienda Policlinico Umberto I, Rome, Italy
Key inclusion criteria (2 listed)
- BMI equal more than 30
- Caucasians
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXADual energy X-ray absorptiometry | Diagnostic test | Patient with sarcopenic obesity, Patients with obesity |
| ultrasonographyultrasonography | Diagnostic test | Patient with sarcopenic obesity, Patients with obesity |
| indirect calorimetryindirect calorimetry | Diagnostic test | Patient with sarcopenic obesity, Patients with obesity |
| MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) | Diagnostic test | Patient with sarcopenic obesity, Patients with obesity |
| bioimpedentiometrybioimpedentiometry | Diagnostic test | Patient with sarcopenic obesity, Patients with obesity |
Primary outcome
Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and AST in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ALT in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GGT in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and alkaline phosphatase in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total bilirubin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and fractionated bilirubin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and triglyceride in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and free fatty acid (FFA) in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total cholesterol in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and HDL-Cholesterol in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and LDL-Cholesterol in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Apo A1 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Apo B in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and serum creatinine in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and blood urea nitrogen in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total proteins in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and albumin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and pseudocholinesterase in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and vitamin D3 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Vitamin B12 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Vitamin B6 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Hs-CRP in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Atrial Natriuretic Peptide (ANP) in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Brain Natriuretic Peptide in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and standard OGTT glycaemia in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and standard OGTT insulin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and C-peptide in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and TSH in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and FT3 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and FT4 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GH in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and IGF-1 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and acylated ghrelin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and unacylated ghrelin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and testosterone (in men) in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and estradiol (in women) in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and adrenal-derived dehydroepiandrosterone in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and myostatin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and leptin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and adiponectin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Irisin in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and parathormone in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and cortisol in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and sodium in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and potassium in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and calcium in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and phosphorus in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and chloride in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and magnesium in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and TNF-α in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 6 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 8 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 10 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 15 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 18 in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and hand-grip strength test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 5- time sit-to-stand test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and balance test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Gait speed 4m in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 6-minute walk test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Knee extension strenght in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Sit and reach test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Time up and go test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and One-Leg Standing balance in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 30s chair stand test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Joint mobility test in Odd Ratios as assessed by Multivariate analysis
Time frame: baseline, 6 month
7 secondary outcomes
Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis
Time frame: baseline, 6 month
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
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
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
Association between diagnostic criteria for Sarcopenic Obesity and appendicular lean mass to weight in Odd Ratios as assessed by multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and bone mineral density in Odd Ratios as assessed by multivariate analysis
Time frame: baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and visceral adipose tissue (assessed by DXA) in Odd Ratios as assessed by multivariate analysis
Time frame: baseline, 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity, run by Elisa Giannetta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Giannetta (0039-0649970711, elisa.giannetta@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis (time frame: baseline, 6 month). The study lists 70 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.