Sarcopenic ObesityOS-BPCONCT06822504
Prevalence of Sarcopenic Obesity in COPD
An observational study of Sarcopenic Obesity and COPD, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
The goal of this observational study is to the purpose is to apply of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Sarcopenic Obesity, COPD
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 30 Jun 2025
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable COPD admitted to the respiratory rehabilitation ward
Who may be able to join
- Patients aged > 40 years of either sex;
- BMI >18.5
- COPD diagnosis according to the GOLD [2021 Global initiative for chronic obstructive lung disease] classification in the stable stage;
- Signing of informed consent after receiving all information about the study.
Who cannot join
- COPD not stabilized at the time of enrollment;
- BMI < 18.5
- presence of tracheostomy
- uncontrolled hypertension (systolic blood pressure > 160 mmHg, diastolic > 100 mmHg);
- hypotension (systolic blood pressure <100 mm Hg);
- Significant comorbidities that limit exercise tolerance;
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- intercurrent infectious diseases, including HIV diagnosis;
- Patients diagnosed with malignancy in progress or in remission for less than 5 years;
- patients diagnosed with severe neurological, rheumatologic, or musculoskeletal diseases;
- patients with a history of thoracic surgery;
- presence of severe aortic stenosis, uncontrolled atrial/ventricular arrhythmia, recent cardiac ischemic event;
- cognitive impairment conditions that prevent full understanding of the study protocol (mental retardation, dementia, etc.) and/or adequate test performance compliance;
- failure to sign informed consent;
- any other serious medical condition that may interfere with data interpretation and safety or that may make the respiratory rehabilitation course difficult, limited, or uncomfortable.
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
IRCCS San Raffaele
Roma, Roma
Franco Pasqua, Prof., +39 0666058336, franco.pasqua@sanraffaele.it
About this study
Official title: ESPEN-EASO Sarcopenic Obesity (OS) Diagnostic Criteria Application in a COPD Cohort and OS Correlation to Diaphragmatic Thickness and Mobility for Determination of Tailored Pulmonary Rehabilitation Program: an Observational Study
The goal of this observational study is to the purpose is to apply of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients.
In addition, this study want to evaluate the impact of sarcopenic obesity on the respiratory function of COPD patients and the degree of severity of respiratory disease, assessed by spirometric examination; diaphragm thickness and excursion, by ultrasonographic study; performance, assessed by six-minute walk test (6-MWT); quality of life and degree of dyspnea (mMRC, Barthel dyspnea, S. George Respiratory Questionnaire); compliance and outcomes at the end of the respiratory rehabilitation course. Comparison with normal-weight patients with and without sarcopenia will help to better understand the clinical impact of sarcopenic obesity in this category of patients.
Read the detailed description
From the review of the literature, there is a wide interest on both excess and deficient malnutrition in COPD patients, and more and more interest is being paid to sarcopenic obesity, which is a clinico-functional condition characterized by the coexisting presence of obesity, characterized by excess fat mass (FM), and sarcopenia, defined as reduced muscle mass and reduced function.
In the literature, there is no unambiguity on the diagnosis of sarcopenic obesity in terms of diagnostic criteria and cut-offs. Only recently, in 2022, have criteria for the diagnosis of sarcopenic obesity been defined through ESPEN/EASO consensus [Donini et al, 2022], shared by the international scientific community (Sarcopenic Obesity Global Leadership Initiative (SOGLI)).
The prevalence of sarcopenia in COPD patients is estimated to be 27% (He et al, 2023).Specifically, on the Italian population, at present it is known that the prevalence of sarcopenia in COPD is 24% (De Blasio et al, 2018), and that the prevalence of sarcopenia in obese individuals in the general population is 20 percent (Poggiogalle et al, 2026) but there are no recent studies showing what is the prevalence of sarcopenic obesity (diagnosed with ESPEN/EASO criteria) in COPD subjects in the Italian population.
This study aims to apply ESPEN/EASO criteria to identify obese sarcopenic patients and calculate the prevalence of sarcopenic obesity in COPD patients.
Finally, with this work, the investigators aim to study the impact of sarcopenic obesity on respiratory function (using both spirometric and ultrasonographic parameters to study the diaphragm), performance, degree of dyspnea, and thus quality of life in COPD patients, emphasizing the importance of early diagnosis in individuals with sarcopenic obesity in order to be able to intervene through targeted nutritional strategies to treat patients with chronic conditions, such as COPD, that significantly impact quality of life and health status.
- Conditions
- Sarcopenic Obesity, COPD
- Keywords
- sarcopenic obesity, COPD, diaphragmatic ultrasound
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | 18.5< BMI > 24.99 | |
| Overweight | 25< BMI > 29.99 | |
| Obese | BMI > 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis and calculation of sarcopenic obesity in COPD
Application of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients.
Sarcopenic obesity (ESPEN/EASO criteria): BMI \&amp;amp;gt; 30 kg/m2 or CV (waist circumference) \&amp;amp;gt; 102 cm M, 88 cm F E Clinical symptoms or clinical suspicion for OS screening or SARC-F ≥ 4 HGS + Sit-to-Stand test + BIA
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jun 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822504
- Sponsor's protocol ID
- 135/SR/24
- Acronym
- OS-BPCO
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESPEN-EASO Sarcopenic Obesity (OS) Diagnostic Criteria Application in a COPD Cohort and OS Correlation to Diaphragmatic Thickness and Mobility for Determination of Tailored Pulmonary Rehabilitation Program: an Observational Study
- ClinicalTrials.gov ID
- NCT06822504
- Acronym / sponsor ID
- OS-BPCO / 135/SR/24
- Conditions
- Sarcopenic Obesity, COPD
- Keywords
- sarcopenic obesity, COPD, diaphragmatic ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 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 goal of this observational study is to the purpose is to apply of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients.
In addition, this study want to evaluate the impact of sarcopenic obesity on the respiratory function of COPD patients and the degree of severity of respiratory disease, assessed by spirometric examination; diaphragm thickness and excursion, by ultrasonographic study; performance, assessed by six-minute walk test (6-MWT); quality of life and degree of dyspnea (mMRC, Barthel dyspnea, S. George Respiratory Questionnaire); compliance and outcomes at the end of the respiratory rehabilitation course. Comparison with normal-weight patients with and without sarcopenia will help to better understand the clinical impact of sarcopenic obesity in this category of patients.
Detailed description
From the review of the literature, there is a wide interest on both excess and deficient malnutrition in COPD patients, and more and more interest is being paid to sarcopenic obesity, which is a clinico-functional condition characterized by the coexisting presence of obesity, characterized by excess fat mass (FM), and sarcopenia, defined as reduced muscle mass and reduced function.
In the literature, there is no unambiguity on the diagnosis of sarcopenic obesity in terms of diagnostic criteria and cut-offs. Only recently, in 2022, have criteria for the diagnosis of sarcopenic obesity been defined through ESPEN/EASO consensus [Donini et al, 2022], shared by the international scientific community (Sarcopenic Obesity Global Leadership Initiative (SOGLI)).
The prevalence of sarcopenia in COPD patients is estimated to be 27% (He et al, 2023).Specifically, on the Italian population, at present it is known that the prevalence of sarcopenia in COPD is 24% (De Blasio et al, 2018), and that the prevalence of sarcopenia in obese individuals in the general population is 20 percent (Poggiogalle et al, 2026) but there are no recent studies showing what is the prevalence of sarcopenic obesity (diagnosed with ESPEN/EASO criteria) in COPD subjects in the Italian population.
This study aims to apply ESPEN/EASO criteria to identify obese sarcopenic patients and calculate the prevalence of sarcopenic obesity in COPD patients.
Finally, with this work, the investigators aim to study the impact of sarcopenic obesity on respiratory function (using both spirometric and ultrasonographic parameters to study the diaphragm), performance, degree of dyspnea, and thus quality of life in COPD patients, emphasizing the importance of early diagnosis in individuals with sarcopenic obesity in order to be able to intervene through targeted nutritional strategies to treat patients with chronic conditions, such as COPD, that significantly impact quality of life and health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | –18.5< BMI > 24.99 |
| Overweight | – | –25< BMI > 29.99 |
| Obese | – | –BMI > 30 |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable COPD admitted to the respiratory rehabilitation ward
Key inclusion criteria (4 listed)
- Patients aged > 40 years of either sex;
- BMI >18.5
- COPD diagnosis according to the GOLD [2021 Global initiative for chronic obstructive lung disease] classification in the stable stage;
- Signing of informed consent after receiving all information about the study.
Key exclusion criteria (14 listed)
- COPD not stabilized at the time of enrollment;
- BMI < 18.5
- presence of tracheostomy
- uncontrolled hypertension (systolic blood pressure > 160 mmHg, diastolic > 100 mmHg);
- hypotension (systolic blood pressure <100 mm Hg);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis and calculation of sarcopenic obesity in COPD
Time frame: From enrollment to the end of treatment at 4 weeks
Application of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients. Sarcopenic obesity (ESPEN/EASO criteria): BMI \&amp;amp;gt; 30 kg/m2 or CV (waist circumference) \&amp;amp;gt; 102 cm M, 88 cm F E Clinical symptoms or clinical suspicion for OS screening or SARC-F ≥ 4 HGS + Sit-to-Stand test + BIA
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 12 Feb 2025.
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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 and COPD, run by IRCCS San Raffaele Roma 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 4 inclusion and 14 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 12 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 Lucia Gatta, PhD (0039 0652253440, lucia.gatta@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis and calculation of sarcopenic obesity in COPD (time frame: From enrollment to the end of treatment at 4 weeks). 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 12 Feb 2025.