Analysis of the Aetiological Factors of Malnutrition: Inflammation and Oral Intake
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Blood biochemistry data
研究概览
简要总结
Disease-related malnutrition (DRM) is a frequent syndrome in clinical practice, in which the mutual relationship between disease and malnutrition is observed. Inflammation, anorexia, changes in body composition or in energy and protein requirements, contribute to the development of DRM. The Global Leadership Initiative on Malnutrition (GLIM criteria) provides a diagnostic system of malnutrition that has been accepted by the main international scientific societies in the field of clinical nutrition.
The GLIM criteria proposes an algorithm that includes phenotypic criteria (weight loss, underweight and low muscle mass), with their corresponding severity thresholds, and aetiological criteria (decreased oral intake, nutrient malabsorption and the presence of an inflammatory component). The diagnosis of malnutrition is established when an aetiological and a phenotypic criterion are met.
The aim of the study is to determine the diagnostic and prognostic value of aetiological factors of malnutrition based on GLIM criteria, presence and degree of inflammation and dietary intake, in patients diagnosed with DRM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DRM based on GLIM criteria with the presence of the aetiological criterion of inflammatory component and candidate for medical nutritional treatment according to current regulations.
- •Agreeing to voluntarily participate in the study and sign the informed consent form, after having read the participant information sheet.
- •Presence of an inflammatory response (CRP>3 mg/dl)
- •Having an adequate cultural level and understanding of the clinical study.
排除标准
- •Pregnant or breastfeeding women
- •Patients with advanced liver cirrhosis or chronic hepatitis (Child=C scale)
- •Patients with advanced neoplastic disease with life expectancy <6 months
- •Patients with renal insufficiency with creatinine clearance less than 45 ml/min
- •Severe infection in the last 3 weeks
- •Taking antibiotic therapy at the time of inclusion, with the exception of prophylactic treatments
- •Taking corticosteroids at the current time or one month prior to inclusion
- •Treatment with biological therapies (antibodies) at the current time or one month in advance
- •Taking non-steroidal anti-inflammatory drugs at the time of inclusion
- •Taking omega 3 supplements for any concomitant pathology at the time of inclusion
- •Undergoing surgery during the follow-up phase of the study
- •Initiation of any drug during the study phase that may modify the patient's inflammatory pattern at the investigator's discretion
- •Any criterion that, in the opinion of the principal investigator, could condition the conduct of the study.
结局指标
主要结局
Blood biochemistry data
时间窗: Patients will be followed over a period of 3 consecutive months
Platelets (x103/μL)
次要结局
- Malnutrition Diagnosis(Patients will be followed over a period of 3 consecutive months)
- Oral intake(Patients will be followed over a period of 3 consecutive months)
- Bioelectrical impedance data (model (50 kHz)(Patients will be followed over a period of 3 consecutive months)
- Functional parameters(Patients will be followed over a period of 3 consecutive months)