Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- BMI (body mass index)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than or equal to 18 years;
- •diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion
排除标准
- •severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min;
- •NYHA class IV;
- •severe liver failure, defined as Child-Pugh score class C;
- •active solid or haematological neoplasms;
- •having already received (currently or in the past) therapy with pirfenidone or nintedanib;
- •inability to walk without help;
- •need for oxygen therapy at rest;
- •participation in other interventional experimental protocols with use of a medicinal product.
结局指标
主要结局
BMI (body mass index)
时间窗: baseline (IPF diagnosis)
kg/m2
FFMI (fat free mass index)
时间窗: baseline (IPF diagnosis)
kg/m2
SMI (skeletal muscle mass index)
时间窗: baseline (IPF diagnosis)
kg/m2
BFMI (body fat mass index)
时间窗: baseline (IPF diagnosis)
kg/m2
Hand Grip
时间窗: baseline (IPF diagnosis)
kg
Abdominal circumference
时间窗: baseline (IPF diagnosis)
cm
Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
时间窗: baseline (IPF diagnosis)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Mini Nutritional Assessment (MNA)
时间窗: baseline (IPF diagnosis)
questionnaire score (maximum score 30): total score \> 23.5 = normal nutritional status; total score \< 23.5 = inadequate nutritional status
次要结局
- Abdominal circumference(6 months after baseline)
- Malnutrition Universal Screening Tool (MUST)(6 months after baseline)
- BMI (body mass index)(6 months after baseline)
- SMI (skeletal muscle mass index)(6 months after baseline)
- Hand Grip(6 months after baseline)
- plasma calcium(baseline (IPF diagnosis) and 6 months after baseline)
- FFMI (fat free mass index)(6 months after baseline)
- plasma vitamin D(baseline (IPF diagnosis) and 6 months after baseline)
- BFMI (body fat mass index)(6 months after baseline)
- Mini Nutritional Assessment (MNA)(6 months after baseline)
研究者
Paola Faverio
Principal Investigator
San Gerardo Hospital