Assessing Fat-free Mass Index in COPD Patients
Prognostic Value of the Fat-free Mass Index on a Multidimensional Scale in Chronic Obstructive Pulmonary Disease
This study looks at whether measuring fat-free mass in COPD patients can give better insights into their health risks compared to the usual body weight measurements.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 237 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05853081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic value of the Fat-free Mass Index (FFMI) in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to traditional measures like Body Mass Index (BMI). It will analyze the nutritional status of COPD patients and compare the mortality and exacerbation risks using various scales, including the BODE and FODE scales. The study will involve a prospective approach with no interventions beyond standard clinical guidelines, and patients will be grouped based on their lung function. Bioelectrical impedance analysis will be used to measure FFMI.
Who should consider this trial
Good fit: Ideal candidates are men and women over 40 years old with a COPD diagnosis of at least two years and a smoking history.
Not a fit: Patients who do not meet the inclusion criteria, such as those with recent exacerbations or changes in COPD treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate prognostic tool for assessing the health and risks of COPD patients.
How similar studies have performed: While the use of FFMI in COPD assessment is gaining interest, this specific approach comparing it to established scales like BODE is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent. * Man or woman \> 40 years. * Smoker or former smoker with a pack-years index ≥ 10. * COPD diagnosis of at least 2 years prior to inclusion in the study, according to the following spirometry criteria: airflow obstruction documented by spirometry after bronchodilator treatment and in the clinical stability phase, with an forced expiratory volume in the first second / forced vital capacity (FEV1/FVC) ratio of less than 0.7, based on the latest GOLD and GesEPOC guidelines.1,14 * Clinical stability will always be defined according to the following criteria: * No evidence of change in COPD maintenance treatment in the 4 weeks prior to inclusion in the study. * No evidence of exacerbation that required the use of systemic antibiotics and/or corticosteroids in at least 4 weeks prior to inclusion in the study. * Patients should be able to perform all procedures necessary for the study at the discretion of the investigator, including: acceptable and reproducible spirometry; 6-minute walking test; bioelectrical impedance analysis Exclusion Criteria: * Patients with another significant disease other than COPD (neoplastic, cardiovascular, metabolic, infectious or any clinical condition) as a foreseeable cause of death in the period of less than one year or that may cause a significant alteration of the nutritional status of the patient. * Taking nutritional supplements and / or anabolic drugs in the last 12 months.
Where this trial is running
Madrid
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Daniel López Padilla, PhD
- Email: lopez.padilla84@gmail.com
- Phone: +34915863330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.