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临床试验/NCT03487536
NCT03487536已完成不适用

Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy

University of Bari1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2006年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
biochemical nutritional assessment

研究概览

简要总结

Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease [body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels], while only two studies have evaluated some of these parameters after PEG placement.

Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.

详细描述

Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit

排除标准

  • ALS patients without PEG

结局指标

主要结局

biochemical nutritional assessment

时间窗: only at the time of PEG placement (one day)

cholesterol levels

nutritional assessment

时间窗: at the time of PEG placement (one day)

Weight and height (combined to report BMI in kg/m\^2)

次要结局

  • body composition assessment(within 2 months from the PEG implantation (one day))

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Barone

Researcher

University of Bari

研究点 (1)

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