Prevalence of Sarcopenic Obesity in COPD

NCT ID: NCT06822504

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 236 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-30

Brief 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.

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.

Conditions

Sarcopenic Obesity; COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal weight

18.5\< BMI \> 24.99

No interventions assigned to this group

Overweight

25\< BMI \> 29.99

No interventions assigned to this group

Obese

BMI \> 30

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS San Raffaele

Roma, Roma, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lucia Gatta, PhD

Role: CONTACT

lucia.gatta@sanraffaele.it

0039 0652253440

Franco Pasqua, MD

Role: CONTACT

franco.pasqua@sanraffaele.it

0039 0652258336

Facility Contacts

Franco Pasqua, Prof.

Role: primary

franco.pasqua@sanraffaele.it

+39 0666058336

Other Identifiers

135/SR/24

Identifier Type: -

Identifier Source: org_study_id