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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:
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| Measure | Description | Time Frame |
|---|---|---|
| BMI (body mass index) | kg/m2 | baseline (IPF diagnosis) |
| FFMI (fat free mass index) | kg/m2 | baseline (IPF diagnosis) |
| SMI (skeletal muscle mass index) | kg/m2 | baseline (IPF diagnosis) |
| BFMI (body fat mass index) | kg/m2 | baseline (IPF diagnosis) |
| Hand Grip | kg | baseline (IPF diagnosis) |
| Abdominal circumference | cm | 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 | 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 | baseline (IPF diagnosis) |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (body mass index) | kg/m2 | 6 months after baseline |
| FFMI (fat free mass index) | kg/m2 | 6 months after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INRCA Casatenovo | Casatenovo | Lecco | Italy | |||
| San Gerardo Hospital |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| SMI (skeletal muscle mass index) | kg/m2 | 6 months after baseline |
| BFMI (body fat mass index) | kg/m2 | 6 months after baseline |
| Hand Grip | kg | 6 months after baseline |
| Abdominal circumference | cm | 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 | 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 | 6 months after baseline |
| plasma calcium | calcium level in plasma | baseline (IPF diagnosis) and 6 months after baseline |
| plasma vitamin D | vitamin D level in plasma | baseline (IPF diagnosis) and 6 months after baseline |
| Monza |
| MB |
| 20900 |
| 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 |