FODEPOC Study: Fat-free Mass Index in Copd

Launched by HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON · May 2, 2023

Keywords

ClinConnect Summary

The FODEPOC Study is a clinical trial designed to understand how well a new measurement called the Fat-Free Mass Index (FFMI) can predict health outcomes in people with Chronic Obstructive Pulmonary Disease (COPD). This study aims to compare the FFMI with the traditional Body Mass Index (BMI) and assess how well these measurements can help predict serious health events, like hospitalizations or deaths, in COPD patients. The trial will involve patients who have been diagnosed with COPD for at least two years and are stable in their condition. Researchers will track participants' health for at least two years, measuring their FFMI and recording any health changes.

To participate, individuals must be over 40 years old, have a history of smoking, and meet specific criteria related to their lung function. Participants will not receive any experimental treatments, but they will follow standard COPD care guidelines. The study is currently recruiting participants and is open to both men and women. It's important to note that those with other major health issues or those taking certain nutritional supplements may not be eligible. By joining the study, participants will contribute to valuable research that may improve the understanding and management of COPD in the future.

Gender

ALL

Eligibility 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.