Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia

NCT ID: NCT06312774

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2027-01-04

Brief 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. 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

Study Design

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

Study Groups

Individuals with Chronic Lung Disease

This is observational study

Intervention Type: OTHER

This is observational study

Healthy Controls

This is observational study

Intervention Type: OTHER

This is observational study

Interventions

This is observational study

This is observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adult patients diagnosed with chronic lung disease (≥ 18years).

2. Only patients who are willing and able to provide informed consent to participate in the study.

Exclusion Criteria

1. 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.

2. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRAS 333853

Identifier Type: -

Identifier Source: org_study_id