SarcopeniaNCT06312774
Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia
An observational study of Sarcopenia and Chronic Lung Disease, run by University College, London.
Trial summary
Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Chronic Lung Disease
- What is being tested?
- This is observational study
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2024to 4 Jan 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sarcopenia, the condition of losing muscle mass and strength as we age, is especially common in older adults who also have chronic lung diseases such as COPD (a type of obstructive lung disease that makes it hard to breathe) and interstitial lung disease (a type of lung disease that affects the tissue and space around the air sacs of the lungs).
Who may be able to join
- Adult patients diagnosed with chronic lung disease (≥ 18years).
- Only patients who are willing and able to provide informed consent to participate in the study.
Who cannot join
- Patients with other major comorbidities that could significantly impact muscle mass and function, such as severe heart failure, advanced liver or kidney disease, uncontrolled diabetes, or malignancies.
- Patients with acute exacerbations of their chronic lung disease or any other acute illness at the time of the study. 3. Patients with a history of neuromuscular disorders or disability that could significantly affect muscle mass and function.
- 4. Patients who have undergone recent surgery in the past 6 months or have received specific treatments that could influence muscle mass and function, such as long-term corticosteroid use, chemotherapy, or radiation therapy.
- 5. Patients with life expectancy of less than 6 months 6. Patients who are unable or unwilling to comply with the study protocol or procedures.
- 7. Patients that are unable to give informed consent.
About this study
Official title: Feasibility Study for Comparative Analysis of Proteome and Single-cell RNA Sequencing in Chronic Lung Disease Patients With and Without Sarcopenia
Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life.
The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia.
The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study.
- Conditions
- Sarcopenia, Chronic Lung Disease
- Being tested
- This is observational study
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is observational studyOther
This is observational study
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Chronic Lung Disease | Not described Receives: Other: This is observational study | |
| Healthy Controls | Not described Receives: Other: This is observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia
feasibility of using the FACS approach and molecular analyses to investigate the association between sarcopenia and chronic lung disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start18 Apr 2024 (estimated)
- Primary completion7 Nov 2025 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312774
- Sponsor's protocol ID
- IRAS 333853
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Comparative Analysis of Proteome and Single-cell RNA Sequencing in Chronic Lung Disease Patients With and Without Sarcopenia
- ClinicalTrials.gov ID
- NCT06312774
- Acronym / sponsor ID
- IRAS 333853
- Conditions
- Sarcopenia, Chronic Lung Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 18 Apr 2024 (estimated)
- Primary completion
- 7 Nov 2025 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life.
The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia.
The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Chronic Lung Disease | – | Other: This is observational study |
| Healthy Controls | – | Other: This is observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sarcopenia, the condition of losing muscle mass and strength as we age, is especially common in older adults who also have chronic lung diseases such as COPD (a type of obstructive lung disease that makes it hard to breathe) and interstitial lung disease (a type of lung disease that affects the tissue and space around the air sacs of the lungs).
Key inclusion criteria (2 listed)
- Adult patients diagnosed with chronic lung disease (≥ 18years).
- Only patients who are willing and able to provide informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Patients with other major comorbidities that could significantly impact muscle mass and function, such as severe heart failure, advanced liver or kidney disease, uncontrolled diabetes, or malignancies.
- Patients with acute exacerbations of their chronic lung disease or any other acute illness at the time of the study. 3. Patients with a history of neuromuscular disorders or disability that could significantly affect muscle mass and function.
- 4. Patients who have undergone recent surgery in the past 6 months or have received specific treatments that could influence muscle mass and function, such as long-term corticosteroid use, chemotherapy, or radiation therapy.
- 5. Patients with life expectancy of less than 6 months 6. Patients who are unable or unwilling to comply with the study protocol or procedures.
- 7. Patients that are unable to give informed consent.
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 |
|---|---|---|
| This is observational studyThis is observational study | Other | Healthy Controls, Individuals with Chronic Lung Disease |
Primary outcome
Sarcopenia
Time frame: 3 years
feasibility of using the FACS approach and molecular analyses to investigate the association between sarcopenia and chronic lung disease
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 15 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Chronic Lung Disease, run by University College, London.
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 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: opening soon, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Sarcopenia (time frame: 3 years). 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 15 Mar 2024.