In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients. Aim of this study is to assess the nutritional status of patients with IPF at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.
Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data regarding this subject are available for patients with IPF. Primary aim of this study is to assess the nutritional status of patients diagnosed with mild to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the prevalence of nutritional disorders at baseline through nutritional scores evaluated with specific questionnaires and through the identification of the following metabolic phenotypes (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status, obesity, sarcopenic obesity. Secondary aims of this study are: * the evaluation of the impact of the introduction of an anti-fibrotic pharmacological agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation of antifibrotic therapy. * the assessment of calcium and vitamin D metabolism, by blood sampling, in patients diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months from the initiation of antifibrotic therapy.
Study Type
OBSERVATIONAL
Enrollment
100
INRCA Casatenovo
Casatenovo, Lecco, Italy
San Gerardo Hospital
Monza, MB, Italy
G. Salvini Hospital
Garbagnate Milanese, Milano, Italy
Ospedale di Circolo
Busto Arsizio, Varese, Italy
Ospedale SS. Annunziata
Chieti, Italy
San Martino Hospital
Genova, Italy
San Giuseppe Hospital
Milan, Italy
San Paolo and San Carlo Hospital
Milan, Italy
Ospedale Maggiore Novara
Novara, Italy
BMI (body mass index)
kg/m2
Time frame: baseline (IPF diagnosis)
FFMI (fat free mass index)
kg/m2
Time frame: baseline (IPF diagnosis)
SMI (skeletal muscle mass index)
kg/m2
Time frame: baseline (IPF diagnosis)
BFMI (body fat mass index)
kg/m2
Time frame: baseline (IPF diagnosis)
Hand Grip
kg
Time frame: baseline (IPF diagnosis)
Abdominal circumference
cm
Time frame: baseline (IPF diagnosis)
Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Time frame: baseline (IPF diagnosis)
Mini Nutritional Assessment (MNA)
questionnaire score (maximum score 30): total score \> 23.5 = normal nutritional status; total score \< 23.5 = inadequate nutritional status
Time frame: baseline (IPF diagnosis)
BMI (body mass index)
kg/m2
Time frame: 6 months after baseline
FFMI (fat free mass index)
kg/m2
Time frame: 6 months after baseline
SMI (skeletal muscle mass index)
kg/m2
Time frame: 6 months after baseline
BFMI (body fat mass index)
kg/m2
Time frame: 6 months after baseline
Hand Grip
kg
Time frame: 6 months after baseline
Abdominal circumference
cm
Time frame: 6 months after baseline
Malnutrition Universal Screening Tool (MUST)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Time frame: 6 months after baseline
Mini Nutritional Assessment (MNA)
questionnaire score (maximum score 30): total score \> 23.5 = normal nutritional status; total score \< 23.5 = inadequate nutritional status
Time frame: 6 months after baseline
plasma calcium
calcium level in plasma
Time frame: baseline (IPF diagnosis) and 6 months after baseline
plasma vitamin D
vitamin D level in plasma
Time frame: baseline (IPF diagnosis) and 6 months after baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.