Sarcopenic ObesityNCT07136246
A Prognostic Model for COPD Complicated With Sarcopenic Obesity Based on Bioelectrical Impedance Phase Angle Technology
An observational study of Sarcopenic Obesity and COPD, run by Fudan University at 1 site in China.
Trial summary
This study aims to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity using multi-segment bioelectrical impedance phase angle technology. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenic Obesity, COPD
- What is being tested?
- InBody S10
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 23 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The elderly COPD patients measured with bioelectrical impedance phase angle technology
Who may be able to join
- Age over 65 years;
- Ability to complete physical activity assessments and pulmonary function tests;
- Complete medical records, willingness to adhere to follow-up arrangements, and provision of adverse event reports via telephone or outpatient visits, with signed informed consent;
- COPD diagnosis based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) GOLD definition, with a post-bronchodilator FEV1/FVC ratio < 0.70, current or former smokers with a smoking history of ≥10 pack-years.
Who cannot join
- Severe cognitive impairment or hand deformities (e.g., rheumatoid arthritis) preventing body composition measurements;
- Incomplete clinical or follow-up data or unwillingness/inability to undergo regular follow-up;
- Severe systemic edema;
- Presence of cardiac pacemakers or significant metal implants that may interfere with measurements;
- Voluntary withdrawal for any reason, including loss to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Huadong hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Research on the Construction of a Prognostic Model for COPD Complicated With Sarcopenic Obesity Based on Bioelectrical Impedance Phase Angle Technology
This study aims to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity using multi-segment bioelectrical impedance phase angle technology. It seeks to clarify the diagnostic value and efficacy of body composition analysis in specific populations, analyze the relationship between phase angle and COPD severity as well as quality of life, investigate its predictive role for adverse outcomes, and reveal the effects of inflammation and metabolic disorders in sarcopenic obesity. The goal is to provide a basis for early screening and precise intervention to improve patient prognosis.
Read the detailed description
The primary objective of this study is to use multi-segment bioelectrical impedance phase angle technology to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity. The study aims to clarify the diagnostic value and efficacy of body composition analysis in specific populations, analyze the relationship between phase angle and COPD severity as well as quality of life, investigate its predictive role for adverse outcomes, and reveal the effects of inflammation and metabolic disorders in sarcopenic obesity. The goal is to provide a basis for early screening and precise intervention to improve patient prognosis.
- Conditions
- Sarcopenic Obesity, COPD
- Being tested
- InBody S10
- 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.
InBody S10Device
Bioelectrical Impedance Phase Angle Technology Measured via InBody S10 at six frequencies (1kHz-1000kHz) during each follow-up
| Study group | Role | What they receive |
|---|---|---|
| COPD with sarcopenic obesity | COPD with sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment Receives: Device: InBody S10 | |
| COPD without sarcopenic obesity | COPD without sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment Receives: Device: InBody S10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pulmonary function
FEV1%
Measured: 6, 12, and 24 months
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) is a short, validated questionnaire used to measure the impact of COPD symptoms on a patient's daily life and health status. It consists of 8 simple questions, each scored from 0 to 5, with a total range of 0-40.Higher CAT scores = Worse COPD symptoms \& greater disease burden
Measured: 6, 12, and 24 months
Body composition
Segmental phase angles measured via bioelectrical impedance analysis
Measured: 6, 12, and 24 months
Dyspnea Scale
The Modified Medical Research Council(mMRC) scale is a simple questionnaire used to assess the severity of breathlessness, primarily in respiratory diseases like COPD.range from 0-4 .Grading Criteria:Grade 1: Short of breath when walking fast or climbing a slight hill.Grade 2: Walk slower than peers or need to stop occasionally due to breathlessness.Grade 3: Stop to breathe after walking ~100 meters or a few minutes on level ground.Grade 4: Too breathless to leave home, or breathless while dressing/undressing.A higher mMRC grade correlates with greater dyspnea severity and more pronounced symptoms."
Measured: 6, 12, and 24 months
Secondary outcomes (8)
Acute exacerbations
An acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is defined as:An acute worsening of respiratory symptoms that results in additional therapy.
Measured: 6, 12, and 24 months
Hospitalizations
Frequency of hospitalizations
Measured: 6, 12, and 24 months
Mortality
Mortality based on Mal-Nutritional Status
Measured: 24 months
CBC
Serum level of WBC (ELISA)
Measured: 6, 12, and 24 months
CRP
Serum level of C-Reactive Protein (ELISA)
Measured: 6, 12, and 24 months
albumin
Serum level of albumin
Measured: 6, 12, and 24 months
IL-6
Serum level of Interleukin-6
Measured: 6, 12, and 24 months
TNF-α
Serum level of Tumor Necrosis Factor-alpha
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Aug 2025
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Yinggang Zhu, MD, PhD, Principal investigator, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136246
- Sponsor's protocol ID
- COSAT
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Construction of a Prognostic Model for COPD Complicated With Sarcopenic Obesity Based on Bioelectrical Impedance Phase Angle Technology
- ClinicalTrials.gov ID
- NCT07136246
- Acronym / sponsor ID
- COSAT
- Conditions
- Sarcopenic Obesity, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 22 Aug 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.
This study aims to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity using multi-segment bioelectrical impedance phase angle technology. It seeks to clarify the diagnostic value and efficacy of body composition analysis in specific populations, analyze the relationship between phase angle and COPD severity as well as quality of life, investigate its predictive role for adverse outcomes, and reveal the effects of inflammation and metabolic disorders in sarcopenic obesity. The goal is to provide a basis for early screening and precise intervention to improve patient prognosis.
Detailed description
The primary objective of this study is to use multi-segment bioelectrical impedance phase angle technology to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity. The study aims to clarify the diagnostic value and efficacy of body composition analysis in specific populations, analyze the relationship between phase angle and COPD severity as well as quality of life, investigate its predictive role for adverse outcomes, and reveal the effects of inflammation and metabolic disorders in sarcopenic obesity. The goal is to provide a basis for early screening and precise intervention to improve patient prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD with sarcopenic obesity | – | Device: InBody S10COPD with sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment |
| COPD without sarcopenic obesity | – | Device: InBody S10COPD without sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The elderly COPD patients measured with bioelectrical impedance phase angle technology
Key inclusion criteria (4 listed)
- Age over 65 years;
- Ability to complete physical activity assessments and pulmonary function tests;
- Complete medical records, willingness to adhere to follow-up arrangements, and provision of adverse event reports via telephone or outpatient visits, with signed informed consent;
- COPD diagnosis based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) GOLD definition, with a post-bronchodilator FEV1/FVC ratio < 0.70, current or former smokers with a smoking history of ≥10 pack-years.
Key exclusion criteria (5 listed)
- Severe cognitive impairment or hand deformities (e.g., rheumatoid arthritis) preventing body composition measurements;
- Incomplete clinical or follow-up data or unwillingness/inability to undergo regular follow-up;
- Severe systemic edema;
- Presence of cardiac pacemakers or significant metal implants that may interfere with measurements;
- Voluntary withdrawal for any reason, including loss to follow-up.
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 |
|---|---|---|
| InBody S10Bioelectrical Impedance Phase Angle Technology Measured via InBody S10 at six frequencies (1kHz-1000kHz) during each follow-up | Device | COPD with sarcopenic obesity, COPD without sarcopenic obesity |
Primary outcome
Changes in pulmonary function
Time frame: 6, 12, and 24 months
FEV1%
COPD Assessment Test (CAT)
Time frame: 6, 12, and 24 months
The COPD Assessment Test (CAT) is a short, validated questionnaire used to measure the impact of COPD symptoms on a patient's daily life and health status. It consists of 8 simple questions, each scored from 0 to 5, with a total range of 0-40.Higher CAT scores = Worse COPD symptoms \& greater disease burden
Body composition
Time frame: 6, 12, and 24 months
Segmental phase angles measured via bioelectrical impedance analysis
Dyspnea Scale
Time frame: 6, 12, and 24 months
The Modified Medical Research Council(mMRC) scale is a simple questionnaire used to assess the severity of breathlessness, primarily in respiratory diseases like COPD.range from 0-4 .Grading Criteria:Grade 1: Short of breath when walking fast or climbing a slight hill.Grade 2: Walk slower than peers or need to stop occasionally due to breathlessness.Grade 3: Stop to breathe after walking ~100 meters or a few minutes on level ground.Grade 4: Too breathless to leave home, or breathless while dressing/undressing.A higher mMRC grade correlates with greater dyspnea severity and more pronounced symptoms."
8 secondary outcomes
Acute exacerbations
Time frame: 6, 12, and 24 months
Hospitalizations
Time frame: 6, 12, and 24 months
Mortality
Time frame: 24 months
CBC
Time frame: 6, 12, and 24 months
CRP
Time frame: 6, 12, and 24 months
albumin
Time frame: 6, 12, and 24 months
IL-6
Time frame: 6, 12, and 24 months
TNF-α
Time frame: 6, 12, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- 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. This study is not recruiting at the moment.
Yinggang Zhu, MD, PhD principal investigator
Huadong Hospital
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 Fudan University at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 26 Jan 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pulmonary function (time frame: 6, 12, and 24 months). The study lists 4 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 26 Jan 2026.